Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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June 6, 2007
07-23

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
a) Chicken Salad Sandwich. Wedge style sandwich wrapped in Modified Atmosphere Packaging (MAP). Packaged under two labels: Tuscan Sun, and LunchBox. Chicken Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen by the firm or the firm’s frozen consignees for up to six (6) months prior to further distribution. Tuscan Sun: Top Label includes 'Tuscan Sun Chicken Salad'. Bottom Label includes 'Tuscan Sun Chicken Salad NET WT. 4.4 OZ. (125g). Chicken Salad: Tuscan Sun UPC code on bottom label includes ''43701 01426''. Production codes: Tuscan Sun Fresh: all codes up to and including 15E, Best Buy 051107. Tuscan Sun Frozen: all codes up to and including 14D. LunchBox: Top Label includes 'Chicken Salad'. Bottom Label includes 'Lunchbox Chicken Salad NET WT. 4.4 OZ. (125g). LunchBox UPC code on top and bottom labels include ''43701 01975'’. Production codes: LunchBox Fresh: all codes up to and including 14D, Best Buy 042707. LunchBox Frozen: all codes up to and including 49D. Chicken Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen for up to six (6) months by Jumbo Foods or their frozen sandwich consignees, Recall # F-283-7;

b) Tuna Salad Sandwich. Wedge style sandwich wrapped in Modified Atmosphere Packaging (MAP). Packaged under two labels: Tuscan Sun, and LunchBox. Tuna Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen by the firm or the firm's frozen consignees for up to six (6) months prior to further distribution. Tuscan Sun: Top Label includes 'Tuscan Sun Tuna'. Bottom Label includes 'Tuscan Sun Tuna Salad NET WT. 4.4 OZ. (125g). Tuna Salad: Tuscan Sun UPC code on bottom label includes ''43701 01454''. Production codes: Tuscan Sun Fresh: all codes up to and including 15E, Best Buy 051107. Tuscan Sun Frozen: all codes up to and including 15D. LunchBox: Top Label includes 'Tuna Salad'. Bottom Label includes 'Lunchbox Tuna Salad NET WT. 4.4 OZ. (125g). LunchBox UPC code on top and bottom labels include ''43701 01964''. Production codes: LunchBox Fresh: all codes up to and including 16C, Best Buy 051107. LunchBox Frozen: all codes up to and including 14D. Tuna Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen for up to six (6) months by Jumbo Foods or their frozen sandwich consignees, Recall # F-284-7;

c) Egg Salad Sandwich. Wedge style sandwich wrapped in Modified Atmosphere Packaging (MAP). Packaged under two labels: Tuscan Sun, and LunchBox. Egg Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen by the firm or the firm's frozen consignees for up to six (6) months prior to further distribution. Top Label includes 'Tuscan Sun Egg'. Bottom Label includes 'Tuscan Sun Egg Salad NET WT. 4.4 OZ. (125g). Egg Salad: Tuscan Sun UPC code on bottom label includes ''43701 01450''. Production codes: Tuscan Sun Fresh: all codes up to and including 15E, Best Buy 051107. Tuscan Sun Frozen: all codes up to and including 14D. LunchBox UPC code on top and bottom labels include ''43701 01960''. Production codes: LunchBox Fresh: all codes up to and including 16C, Best Buy 051107. LunchBox Frozen: all codes up to and including 14D. LunchBox: Top Label includes 'Egg Salad'. Bottom Label includes 'Lunchbox Egg Salad NET WT. 4.4 OZ. (125g). Egg Salad sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen for up to six (6) months by Jumbo Foods or their frozen sandwich consignees, Recall # F-285-7;

d) Smoked Turkey Sandwich. Wedge style sandwich wrapped in Modified Atmosphere Packaging (MAP). Packaged under two labels: Tuscan Sun, and LunchBox. Smoked Turkey sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen by the firm or the firm's frozen consignees for up to six (6) months prior to further distribution. Tuscan Sun: Top Label includes 'Tuscan Sun Smoked Turkey'. Bottom Label includes 'Tuscan Sun Smoked Turkey NET WT. 5.4 OZ. (153g). Smoked Turkey: Tuscan Sun UPC code on bottom label includes ''43701 01449''. Production codes: Tuscan Sun Fresh: all codes up to and including 15E, Best Buy 051107. Tuscan Sun Frozen: all codes up to and including 32E. LunchBox UPC code on top and bottom labels include ''43701 01976''. Production codes: LunchBox Fresh: all codes up to and including 12C, Best Buy 041307. LunchBox Frozen: all codes up to and including 14D. Lunch Box: Top Label includes 'Smoked Turkey'. Bottom Label includes 'Lunchbox Smoked Turkey NET WT. 5.4 OZ. (153g), Smoked Turkey sandwiches under both labels may be sold fresh or frozen. Frozen products may be stored frozen for up to six (6) months by Jumbo Foods or their frozen sandwich consignees, Recall # F-286-7;
CODE
a) An adhesive ink stamped ''Best Buy'' label is applied to product when ready to be shipped to customer. ''Best Buy'' codes are six digit numeric date codes as exampled by ''051107'' where 05=Month, 11=Day, and 07=Year (2007). Sandwiches stored fresh are given a ''Best Buy'' date by Jumbo Foods prior to further distribution. Product stored frozen are given a ''Best By'' date by the frozen consignees when product is to be further shipped to retail and vendor customers. Sandwiches, fresh and frozen (Tuscan Sun and LunchBox) are also ink stamped by Jumbo Foods with a three digit alpha-numeric manufacturer code at the bottom right hand corner on the top label, i.e. 06D where ''06'' is the numeric week of the year and ''D'' is the specific day manufactured (A=Monday, B=Tuesday, C=Wednesday, D=Thursday, etc.).

b) An adhesive ink stamped ''Best Buy'' label is applied to product when ready to be shipped to customer. ''Best Buy'' codes are six digit numeric date codes as exampled by ''051107'' where 05=Month, 11=Day, and 07=Year (2007). Sandwiches stored fresh are given a ''Best Buy'' date by Jumbo Foods prior to further distribution. Product stored frozen are given a ''Best By'' date by the frozen consignees when product is to be further shipped to retail and vendor customers. Sandwiches, fresh and frozen (Tuscan Sun and LunchBox) are also ink stamped by Jumbo Foods with a three digit alpha-numeric manufacturer code at the bottom right hand corner on the top label, i.e. 06D where ''06'' is the numeric week of the year and ''D'' is the specific day manufactured (A=Monday, B=Tuesday, C=Wednesday, D=Thursday, etc.).

c) An adhesive ink stamped ''Best Buy'' label is applied to product when ready to be shipped to customer. ''Best Buy'' codes are six digit numeric date codes as exampled by ''051107'' where 05=Month, 11=Day, and 07=Year (2007). Sandwiches stored fresh are given a ''Best Buy'' date by Jumbo Foods prior to further distribution. Product stored frozen are given a ''Best By'' date by the frozen consignees when product is to be further shipped to retail and vendor customers. Sandwiches, fresh and frozen (Tuscan Sun and LunchBox) are also ink stamped by Jumbo Foods with a three digit alpha-numeric manufacturer code at the bottom right hand corner on the top label, i.e. 06D where ''06'' is the numeric week of the year and ''D'' is the specific day manufactured (A=Monday, B=Tuesday, C=Wednesday, D=Thursday, etc.).

d) An adhesive ink stamped ''Best Buy'' label is applied to product when ready to be shipped to customer. ''Best Buy'' codes are six digit numeric date codes as exampled by ''051107'' where 05=Month, 11=Day, and 07=Year (2007). Sandwiches stored fresh are given a ''Best Buy'' date by Jumbo Foods prior to further distribution. Product stored frozen are given a ''Best By'' date by the frozen consignees when product is to be further shipped to retail and vendor customers. Sandwiches, fresh and frozen (Tuscan Sun and LunchBox) are also ink stamped by Jumbo Foods with a three digit alpha-numeric manufacturer code at the bottom right hand corner on the top label, i.e. 06D where ''06'' is the numeric week of the year and ''D'' is the specific day manufactured (A=Monday, B=Tuesday, C=Wednesday, D=Thursday, etc.).
RECALLING FIRM/MANUFACTURER
Jumbo Foods Inc, Mukilteo, WA, by e-mail and telephone on April 23, 2007 and by visit between April 23, 2007 through April 26, 2007. Firm initiated recall is ongoing.
REASON
The product lists whey as an ingredient but does not list milk as the source of the whey as required by FALCPA (Food Allergen Labeling and Consumer Protection Act).
VOLUME OF PRODUCT IN COMMERCE
79,794 sandwiches
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Flora Italian Foods brand Cerignola Olives packed in brine, in 580 ml. glass jars, UPC 0-20038-00693-5, Recall # F-287-7
CODE
Lot: G080
RECALLING FIRM/MANUFACTURER
Recalling Firm: Flora Foods, Inc., Pompano Beach, FL, by letter on February 26, 2007, and by press release on March 9, 2007.
Manufacturer: Charlie Brown of Rutigliano & Figli S.r.l, Binetto, Italy. Firm initiated recall is ongoing.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not be adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
682 cases
DISTRIBUTION
FL, GA, and NY
___________________________________
PRODUCT
a) Dal Raccolto brand Italian Green Colossal Olives, Product of Italy, in glass jars
    with Net Drained Weight 4.18 lb. (1.9 kg). Product has UPC 0 32762 60006 8,
    Recall # F-288-7;
b) Dal Raccolto brand Natural Cerignola Olives, Product of Italy in glass jars with
    Net Drained Weight 4.18 lb (1.9 kg). Product has UPC 0 32762 60009 9,
    Recall # F-289-7;
c) Dal Raccolto brand Black Cerignola Olives, Product of Italy packed in 2.5 kg tins,
    Recall # F-290-7;
d) Dal Raccolto brand Red Cerignola Olives, Product of Italy, in glass jars with
    Net Drained Weight 4.18 lb. (1.9 kg). Product has UPC 0 32762 60004 1,
    Recall # F-291-7;
e) Dal Raccolto brand Green Cerignola Olives, Product of Italy, in glass jars with
    Net Drained Weight 4.18 lb. (1.9 kg). Product has UPC 0 32762 60002 0,
    Recall # F-292-7;
f) Dal Raccolto brand Baresana Olives, Product of Italy, in plastic tubs with Net
    Drained Weight 11 lb. (5 kg). Product has UPC 0 32762 60008 2, Recall # F-293-7;
g) Dal Raccolto brand Nocellara Olives, Product of Italy, in plastic tubs with Net
    Drained Weight 11 lb (5 kg). Product has UPC 0 32762 60012 9, Recall # F-294-7;
h) Dal Raccolto brand Calabrese Olives, Product of Italy, in plastic tubs with Net
    Drained Weight 11 lb. (5 kg). Product has UPC 0 32762 60007 5, Recall # F-295-7
CODE
a), b), and e) Lot G062;
c) Lot G066, G009;
d) Lot G046;
f) and h) Lot G198;
g) Lot G216 and G217
RECALLING FIRM/MANUFACTURER
Recalling Firm: Colavita USA Inc, Linden, NJ, by letter on February 9, 2007.
Manufacturer: Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy. Firm initiated recall is ongoing.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not be adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
422 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Cento Imported Natural Cerignola Olives 5 lb. plastic tub
    Nt. Wt. 5 lbs (2.27 kg). Product of Italy UPC 0 70796 60064 7,
    Recall # F-296-7;
b) Cento Imported Red Cerignola Olives 4.4 lb. glass jar Nt. Wt.
    4.40 lbs (2kg), Product of Italy. UPC 0 70796 60065 4, Recall # F-297-7;
c) Cento Imported Green Cerignola Olives 4.4 lb. glass jar Nt. Wt.
    4.4 lbs (2kg). Product of Italy. UPC 0 70796 60066 1, Recall # F-298-7;
d) Cento Imported Black Oven Baked Olives 5 lb. aluminum tin Net
    Drained Weight 5 lbs (2.27 kg). Packed in Italy UPC 0 70796 60070 8,
    Recall # F-299-7;
e) Cento Imported Nocellara Olives 5 lb. plastic tub Net Drained Weight
    5 lbs, (2.27g). Product of Italy UPC 0 70796 60068 5, Recall # F-300-7;
f) Cento Imported Castelvetrano Olives 5 lb. plastic tub New Drained Wt.
    5 lbs. (2.27kg). Product of Italy UPC 0 70796 60072 2, Recall # F-301-7;
CODE
All lots starting with G (indicates 2006)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alanric Food Distributors, Inc., Thorofare, NJ, by telephone and letter beginning on April 17, 2007.
Manufacturer: Charlie Brown di Rutigliano & Figli S.r.l., Binetto, Italy. Firm initiated recall is ongoing.
REASON
The product was manufactured under conditions whereby it may have been rendered hazardous to health. It may not be adequately processed to prevent the growth of harmful bacteria such as those which cause botulism.
VOLUME OF PRODUCT IN COMMERCE
4,284 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
a) ACETAMINOPHEN 325MG TABLET, 250 count bags (NDC #61392000525);
    30 count bingo card (NDC #61392000539); 60 count bingo card (NDC #61392000565);
    and 30 count boxes (NDC #61392000530), OTC, Recall # D-735-2007;
b) ACETAMINOPHEN 500MG CAPLET, 250 count bags (NDC #61392094825) &
   30 count boxes (NDC #61392094830), OTC, Recall # D-736-2007;
c) ACETAMINOPHEN 500MG GELCAP, 30 count bingo card (NDC #61392064439),
  OTC, Recall # D-737-2007;
d) ACETAMINOPHEN 500MG TABLET, 250 count bags (NDC #61392003025),
    30 count bingo card (NDC #61392003039), 30 count boxes (NDC #61392003030) &
    60 count boxes (NDC #61392003060), OTC, Recall # D-738-2007;
e) ACETAMINOPHEN/COD#3 300/30MG TABLET (c), 30 count bingo card
    (NDC #61392071439) & 31 count bingo card (NDC #61392071431), Rx,
    Recall # D-739-2007;
f) ACETAMINOPHEN/COD#4 300/60MG TABLET (c), 30 count bingo card
    (NDC #61392002839), Rx, Recall # D-740-2007;
g) ACETAZOLAMIDE 250MG TABLET, 30 count bingo card (NDC #61392017639),
    Rx, Recall # D-741-2007;
h) ALBUTEROL SULFATE 2MG TABLET, 30 count bingo card (NDC #61392056739)
    Rx, Recall # D-742-2007;
i) ALBUTEROL SULFATE 4MG TABLET, 30 count bingo card (NDC #61392057039),
   Rx, Recall # D-743-2007;
j) ALLOPURINOL 100MG TABLET, 250 count bags (NDC #61392010325),
    30 count bingo card (NDC #61392010339), 30 count boxes (NDC #61392010330), &
    60 count boxes (NDC #61392010360), Rx, Recall # D-744-2007;
k) ALLOPURINOL 300MG TABLET, 250 count bags (NDC #61392010425) & 30 count
   boxes (NDC #61392010430), Rx, Recall # D-745-2007;
l) ALPRAZOLAM 0.25MG TABLET (c), 30 count bingo card (NDC #61392003439),
    31 count bingo card (NDC #61392003431) & 15 count bingo card (NDC #61392003439),
    Rx, Recall # D-746-2007;
m) ALPRAZOLAM 0.5MG TABLET (c), 30 count bingo card (NDC #61392003539,
    31 count bingo card (NDC #61392003531) & 15 count bingo card (NDC #61392003505),
    Rx, Recall # D-747-2007;
n) ALPRAZOLAM 1MG TABLET (c), 30 count bingo card (NDC #61392003639),
    Rx, Recall # D-748-2007;
o) AMANTADINE 100MG CAPSULE, 250 count bags (NDC #61392004225),
    30 count bingo card (NDC #61392004239) & 30 count boxes (NDC #61392004230),
    Rx, Recall # D-749-2007;
p) AMIODARONE 200MG TABLET, 250 count bags (NDC #61392093525),
    30 count boxes (NDC #61392093530) & 60 count boxes (NDC #61392093560),
    Rx, Recall # D-750-2007;
q) AMITRIPTYLINE 100MG TABLET, 30 count bingo card (NDC #61392015339),
    Rx, Recall # D-751-2007;
r) AMITRIPTYLINE 25MG TABLET, 30 count boxes (NDC #61392014030)
    Rx, Recall # D-752-2007;
s) AMITRIPTYLINE 50MG TABLET, 30 count bingo card (NDC #61392014139),
    Rx, Recall # D-753-2007;
t) ASPIRIN 325MG TABLET, 250 count bags (NDC #61392003325), 30 count
    bingo card (NDC #61392003339), & 30 count boxes (NDC #61392003330), OTC,
    Recall # D-754-2007;
u) ASPIRIN BUFFERED 325MG TABLET, 250 count bags (NDC #61392003125),
    30 count bingo card (NDC #61392003139), & 30 count boxes (NDC #61392003130),
    OTC, Recall # D-755-2007;
v) ASPIRIN CHEW 81MG TABLET, 250 count bags (NDC #61392003225),
    30 count bingo card (NDC #61392003239), 31 count bingo card (NDC #61392003231),
    & 30 count boxes (NDC #61392003230), OTC, Recall # D-756-2007;
w) ASPIRIN EC 325MG TABLET, 250 count bags (NDC #61392089925), & 30 count
    boxes (NDC #61392089930), Recall # D-757-2007;
x) ASPIRIN EC 81MG TABLET, 250 count bags (NDC #61392009625), OTC,
    Recall # D-758-2007;
y) ATENOLOL 100MG TABLET, 250 count bags (NDC #61392054625) & 30 count
     boxes (NDC #61392054630), Rx, Recall # D-759-2007;
z) ATENOLOL 25MG TABLET, 250 count bags (NDC #61392054225), 30 count
    bingo card (NDC #61392054239), 31 count bingo card (NDC #61392054231),
    30 count boxes (NDC #61392054230), 60 count boxes (NDC #61392054260)
    and 15 count bingo card (NDC #61392054205), Rx, Recall # D-760-2007;
aa) ATENOLOL 50MG TABLET, 150 count bags (NDC #61392054325), 30 count
    boxes (NDC #61392054330) & 60 count boxes (NDC #61392054360), Rx,
    Recall # D-761-2007;
bb) AZATHIOPRINE 50MG TABLET, 30 count bingo card (NDC #61392080439),
    Rx, Recall # D-762-2007;
cc) BACLOFEN 10MG TABLET, 250 count bags (NDC #61392070625),
    30 count bingo card (NDC #61392070639) & 30 count boxes (NDC #61392070630),
    Rx, Recall # D-763-2007;
dd) BACLOFEN 20MG TABLET, 30 count bingo card (NDC #61392070739),
    Rx, Recall # D-764-2007;
ee) BENZONATATE 100MG CAPSULE, 250 count bags (NDC #61392057225) &
    30 count boxes (NDC #61392057230), Rx, Recall # D-765-2007;
ff) BENZTROPINE 0.5MG TABLET, 250 count bags (NDC #61392016725) &
    30 count boxes (NDC #61392016730), Rx, Recall # D-766-2007;
gg) BENZTROPINE 1MG TABLET, 250 count bags (NDC #61392017025),
    30 count bingo card (NDC #61392017039), 31 count bingo card
   (NDC #61392017031) & 30 count boxes (NDC #61392017030),
    Rx, Recall # D-767-2007;
hh) BENZTROPINE 2MG TABLET, 250 count bags (NDC #61392016425) &
    30 count boxes (NDC #61392016430), Rx, Recall # D-768-2007;
ii) BISACODYL 5MG TABLET, 250 count bags (NDC #61392017325) &
    30 count boxes (NDC #61392017330), OTC, Recall # D-769-2007;
jj) BUMETANIDE 0.5MG TABLET, 250 count bags (NDC #61392004825),
    30 count bingo card (NDC #61392004839), & 30 count boxes (NDC #61392004830)
    Rx, Recall # D-770-2007;
kk) BUMETANIDE 1MG TABLET, 250 count bags (NDC #61392004925) & 30 count
    boxes (NDC #61392004930), Rx, Recall # D-771-2007;
ll) BUMETANIDE 2MG TABLET, 250 count bags (NDC #61392005025), 30 count
     bingo card (NDC #61392005039), 30 count boxes (NDC #61392005030), Rx,
     Recall # D-772-2007;
mm) BUPROPION 100MG TABLET, 250 count bags (NDC #61392099725),
     30 count bingo card (NDC #61392099739), 30 count boxes (NDC #61392099730),
     Rx, Recall # D-773-2007;
nn) BUPROPION 75MG TABLET, 250 count bags (NDC #61392099625),
     30 count bingo card (NDC #61392099639), 30 count boxes (NDC #61392099630),
     Rx, Recall # D-774-2007
oo) BUSPIRONE 10MG TABLET, 30 count bingo card (NDC #61392066139),
     30 count boxes (NDC #61392066130), & 60 count boxes (NDC #61392066160),
     Rx, Recall # D-775-2007;
pp) BUSPIRONE 5MG TABLET, 30 count boxes (NDC #61392066030) &
     60 count boxes (NDC #61392066060), Rx, Recall # D-776-2007;
qq) BUSPIRONE 7.5MG TABLET, 250 count bags (NDC #61392066225),
    30 count bingo card (NDC #61392066239), 30 count boxes (NDC #61392066230)
    & 60 count boxes (NDC #61392066260), Recall # D-777-2007;
rr) CAPTOPRIL 12.5MG TABLET, 250 count bags (NDC #61392060425) & 30 count
    boxes (NDC #61392060430), Rx, Recall # D-778-2007;
ss) CAPTOPRIL 25MG TABLET, 250 count bags (NDC #61392060525), 30 count
    bingo card (NDC #61392060539) & 30 count boxes (NDC #61392060530), Rx,
    Recall # D-779-2007;
tt) CAPTOPRIL 50MG TABLET, 30 count bingo card (NDC #61392014739), Rx,
    Recall # D-780-2007
CODE
a) All Lot Codes: U36506A25, U36506B25, U37138C25, U37493B25, U37493D25,
    U37273A25, U38528B25, U37850C25, U39336A25, C39967B25, U40129D25,
    C43327R25, 005E0501, 005G0519, 005J0508, 005J0523, 005k0513, 005L0522,
    005M0544, 005A0608, 005A0658, 005F0508, 0005h0513, 005K0536, 005A0643,
    U36274D30, U36274F30, U37138A30, U36506C30, U37138B30, U37138D30,
    37493C30, U36916A30, U37850A30, U37138E30, U37850B30, U38528A30,
    U39046A30, U39336B30, U39670A30, U38774C30, C39967A30, U40129A30,
    U40129E30, C43327A30, C43695A30, C43327R30, U36274A60, U36274B60,
    U36274C60, U36274E60, U37493A60, U38528C60, U38774A60, U38774B60,
    U40129B60, U39999A60, U40129C60, C43695B60, C43327R60;
b) All Lot Codes: C43727B25, U36270C30;
c) Code Information : All Lot Codes: 39906, 644B0633, 42356;
d) All Lot Codes: U36511B25, U37533B25, U37847C25, U39882B25, 030E0501, 37028,
    030F0520, 030G0507, 030h0513, 030J0508, 030k0510, 030k0545, 030L0532, 030M0527,
    030A0609, U36241A30, U36511C30, U36915A30, U37141B30, U37533D30, U37533C30,
    U37847A30, 38196A30, U37847B30, U37847E30, U39377A30, U38850B30, U39882A30,
    U39882D30, U40205A30, U36511A60, U37141A60, U36241B60, U37533A60, U36915B60,
    U38196B60, U37847D60, U38850A60, U39882C60;
e) All Lot Codes: 714D0512, 714G0505, 714G0507, 714H0509, 38157, 38155, 714J0517,
    714J0518, 714J0514, 38463, 714k0507, 38800, 714L0522, 714A0638, 714B0632, 714C0629,
    714E0608, 714F0616, 37434, 38998, 714M0527;
f) All Lot Codes: 40993, 41391, 42025;
g) All Lot Codes: 36733, 176F0504, 176H0533, 176L0536, 176E0623;
h) All Lot Codes: 36398, 36999, 567h0509;
i) All Lot Codes: 36608, 38156, 570A0624;
j) All Lot Codes: U36142B25, U36142F25, U36142D25, U36142G25, U37172B25,
    U38561A25, U38561B25, U38725B25, U39746B25, U39746D25, U41327A25,
    103D0505, 103E0501, 103F0520, 103G0510, 103h0513, 103J0523, 103K0538,
    103l0518, 103L0541, 103M0511, 103A0614, 103A0636, U36142C30, U36142E30,
    U36834A30, U36142H30, U37172A30, U36834B30, U37172C30, U37172D30,
    U38725A30, U39746A30, U38725C30, U39746C30, U38561C30, U40717A30,
    U41327B30, U42625A30, U43312A30, C43579A30, U36142A60;
k) All Lot Codes: U38726A25, U38726B30, U38726C30, U41627A30, U43388A30,
    U43388B30;
l) All Lot Codes: 034G0503, 034H0511, 034j0509, 034J0525, 034j0531, 034k0528,
    034k0548, 034L0538, 034M0525, 034A0639, 034B0605, 034C0605, 034D0607,
    034E0622, 034F0633, 034k0527, 034L0536, 034E0623, 034D0621;
m) All Lot Codes: 035G0507, 035h0511, 035j0531, 035K0548, 035M0530, 035M0546,
    035B0646, 035C0605, 035D0608, 035E0608, 035F0633, 40083, 40518, 41905,
   035F0603;
n) All Lot Codes: 036k0546, 036L0511, 036M0544, 036A0639, 636B0621, 41056,
    036C0605, 036E0608;
o) All Lot Codes: U37170C25, U37170B25, U39881D25, U41176B25, 042F0504,
    042k0524, 042L0518, 042M0525, 042A0638, 042A0653, 042B0626, 42693, 42694,
    042F0612, U36643A30, U36643B30, U37170A30, U38531A30, U38531B30,
  U39881A30, U39881C30, U39881B30, U39881E30, U41176A30, U41176C30;
p) Code Information : All Lot Codes: U37161B25, U37161D25, U39023A25,
    U39740E25, U41251A25, U47323A25, U37161A30, U37161C30, U37161E30,
    U39023B30, U39740A30, U39740B30, U39740D30, U41251C30, U47323C30,
    U39740C60, U41251B60, U47323B60;
q) All Lot Codes: 36386, 37973, 39051, 153M0544;
r) All Lot Codes: U41377A30;
s) All Lot Codes: 36994, 141h0509, 141k0538, 40736, 141C0616, 141F0612;
t)   All Lot Codes: U37142A25, U37142B25, U37886C25, U37886B25, U38961B25,
    U39317A25, U39916C25, U39916D25, U40206B25, U40824B25, C41132B25,
    C41883B25, U41650A25, 36459, 033H0509, 033h0513, 033K0519, 033k0545,
    39434, 39435, 033M0530, 033M0547, 033A0656, 033B0631, 41738, 033E0602,
    033F0601, 033G0606, 033F0606, U36565A30, U36565B30, U36919A30, U37142C30,
    U37142D30, U37886A30, U37886D30, U38961A30, U38961C30, U39317B30,
    U39916A30, U38961D30, U39916B30, U40206A30, U39916E30, U40206C30,
    U40824A30, U40824C30, C41132A30, C41883A30;
u) All Lot Codes: U40954B25, 36387, 39788, 42493, U40954A30, U40954C30;
v) All Lot Codes: U38529B25, U39936A25, U39936C25, U39936D25, U40391C25,
    U40669B25, C41025B25, U41649A25, U41649B25, C42377B25, C42652B25,
    C43074B25, U43267A25, 032K0508, 032k0542, 032M0520, 032A0616, 032A0654,
    032B0627, 032B0645, 032E0608, 032F0626, 032G0601, 032F0609, U38529A30,
    U39375A30, U39603B30, U39375B30, U39603A30, U39936B30, U39936E30,
    U40345A30, U40391A30, U40391B30, U40669A30, U40541A30, U40669C30,
    C41025A30, C42377A30, C42652A30, C43074A30;
w) All Lot Codes: U36332A25, U36332C25, U37257B25, U37562A25, U38479A25,
    U39024B25, U40452C25, C41133B25, U41997A25, U41594A25, U36332B30,
    U36635A30, U36635B30, U37257A30, U37257C30, U38479B30, U36332D30,
    U37562B30, U39024B30, U39024C30, U39478A30, U36332E30, U39960A30,
    U39960B30, U39024D30, U40452A30, U40452B30, U40452D30, U40665A30,
    U40452E30, C41133A30, U4199730, U41594B30;
x) All Lot Codes: U41275A25, U41275B25;
y) All Lot Codes: U41445A25, U41445B30;
z) All Lot Codes: U37948A25, U38512C25, U39805C25, U40283C25, U40283B25,
    U41378A25, U42994A25, 542H0504, 542J0517, 542K0516, 542L0515, 542M0516,
    542A0605, 542A0654, 542A0655, 524C0615, 542D0602, 542E0608, 542E0609,
    542E0620, 542E0628, 542F0612, 542D0619, 542E0603, 542E0625, U37948B30,
    U38512A30, U38963A30, U39343B30, U39805A30, U39805C30, U40283A30,
    U40630B30, U41005A30, U41378C30, U42230A30, U42781A30, U42994B30,
    U38512B60, U39343A60, U40630A60, U41005B60, U41378B60, 542D0606;
aa) All Lot Codes: U36567D25, U36979A25, U36979C25, U37949A25, U37264C25,
    U37673B30, U38568B25, U39852A25, U39852D25, U39852E25, U39934B25,
    U39852J25, U41964C25, U42665A25, U36567A30, U36567C30, U37264A30,
    U36979D30, U37673A30, U37949B30, U38568A30, U38730A30, U38730B30,
    U38568C30, U39852B30, U39934A25, U39852F30, U39852G30, U39852H30,
    U39852K30, U41964B30, U42665B30, U36567B60, U36979B60, U37264B60,
    U39852C60, U41964A60;
bb) All Lot Codes: 40299, 40812, 41385, 42542;
cc) All Lot Codes: U38343B25, U39452A25, U40676B25, U40956A25, U41636A25,
    706J0522, 706k0539, 706L0512, 706L0530, 706A0605, 705A0621, 706A0641,
    706D0607, 706F0609, 706FO620, 706E0620, U37811A30, U38343A30, U38343C30,
    U39452B30, U40676A30, U40956B30, U41636B30;
dd) All Lot Codes: 707J0522, 707K0539, 707L0530, 707L0544, 707A0657,
    707B0618, 707D0602, 707D0615, 707D0627, 707F0622;
ee) All Lot Codes: U38359C25, U40402C25, U41020A25, U38359A30, U38359B30,
    U38359D30, U40402A30, U40402B30, U40402D30, U41020B30, U41020C30,
    U41240A30;
ff) All Lot Codes: U36885A25, U37531B25, U38323B25, U39785A25, U39785D25,
    U39785C25, U40592B25, U41214A25, U36885A30, U37531A30, U37531C30,
    U37531D30, U38323A30, U39262A30, U39262B30, U39785E30, U39785B30,
    U40346A30, U40592A30, U40592C30, U41214B30;
gg) All Lot Codes: U36887A25, U37907A25, U38391B25, U38391C25, U38916A25,
    U39180A25, U39856A25, U39856C25, U39856D25, U41425A25, U42607B25,
    U43121A25, U43531A25, 36589, 36868, 170F0513, 170G0519, 170H0513,
    170J0504, 170k0510, 170l0505, 170M0522, 170A0614, 170A0627, 170B0636,
    170D0627, 170E0633, 42084, 170D0630, U36887A30, U37565A30, U37565B30,
    U37907B, U37907C30, U38391A30, U37565C30, U38391D30, U38916B30,
    U39180B30, U39856A30, U39856E30, U40711A30, U41425B30, U41944A30,
    U42607A30, U43121B30, U43531B30;
hh) All Lot Codes: U36891A25, U37351B25, U41243A25, U42515A25, U36891A30,
    U37351A30, U37351C30, U41243B30, U42515B30;
ii) All Lot Codes: U36324C25, U37530B25, U38565C25, U39481A25, U39912D25,
   U41125A25, U41813B25, U42997A25, U43458A25, U36324A30, U36528B30,
    U36728A30, U37530A30, U37530D30, U37911A30, U38565B30, U38908A30,
    U38565D30, U37530F30, U38908B30, U39481A30, U39912A30, U39912C30,
    U39912E30, U40593A30, U41813C30, U42997C30, U43458B30, U43458C30,
    U36324B60, U36528A60, U36324D60, U37530C60, U37530E60, U38565A60,
    U39912B60, U41125B60, U41813A60, U42997B60;
jj) All Lot Codes: U39604A25, U39604B25, U39604D25, U39604E25, U39604F25,
    048A0646, 048E0601, U39604C30;
kk) All Lot Codes: U39914B25, U39914C25, U39914A30, U39914D30, U41088A30;
ll) All Lot Codes: U40829B25, U41245B25, 39429, 050L0533, 050B0603, 050B0645,
    41774, 050E0601, U40829A30, U41245A30, U41245C30;
mm) All Lot Codes: U41449B25, 997M0511, 997A0621, 997B0622, 997C0629,
    997E0601, U41449A30;
nn) All Lot Codes: U37494A25, U41247A25, 37487, 38171, 39401, 996M0528,
     996B0639, 996D0608, 42748, 42749, U37494A30, U41247B30;
oo) All Lot Codes: 661E0508, 661F0507, 37440, 661G0509, 661H0508, 38192,
    661h0533, 661K0518, 661k0544, 661k0550, 661M0530, 661A0650, U38473A30,
    U38473C30, U39520A30, U39520B30, U39933B30, U39933C30, U40357A30,
    U40357C30, U39933D30, U38473B, U39933A25, U40357B60, U41250A60;
pp) All Lot Codes: U37945B30, U37945C30, U38480A30, U40397B30, U40633B30,
     U40633A30, U41441B60, U42106B30, U37945A60, U40397A60, U41441A60, U42106A60;
qq) All Lot Codes: U40634A25, U40634E25, U41652A25, 38835, 662M0502, 662MO529,
    40968, 662C0626, 662E0603, U39183B30, U40634B30, U40634D30, U40634F30,
    U41652C30, U39183A60, U40634C60, U41652B60;
rr) All Lot Codes: U41426A25, U41426B30;
ss) All Lot Codes: U41290A25, U42105B25, 605G0516, 605k0536, 605L5018,
    605M0539, 605A0616, 605B0622, 43034, U41290B30, U42105A30;
tt) All Lot Codes: 147F0508, 147K0538, 147A0610, 147G0604
RECALLING FIRM/MANUFACTURER
Heartland Repack Services LLC, Toledo, OH, by telephone between February 14 and February 20, 2007. Firm initiated recall is ongoing.
REASON
Misbranding. There is the possibility of multiple product packaging mix-ups. An OTC drug, Rx drug, or nutritional supplement other than what is indicated on the product labeling, may be inside the packaging.
VOLUME OF PRODUCT IN COMMERCE
566,734,636 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Midazolam HCl Injection, 5mg/5mL (1 mg/mL), 5mL Vials, Rx only, For IM or IV Use Only, Recall # D-800-2007
CODE
06P0671A; 06P0641A; 06P0711A; 06P0721A; 06P0731A. All have exp. of October, 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter, New Providence, NJ, by letter on April 10, 2007.
Manufacturer: MOVA Pharma Corp., Caguas, PR. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility; leaking closure and white crusted powder near neck of the vial.
VOLUME OF PRODUCT IN COMMERCE
321,300 vials
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
AMPicillin and Sulbactam for Injection, USP, 3g/ 20mL Vial and 15g/100mL Pharmacy Bulk Package, Sterile, For Intravenous Use Only, -NDC 10019-630-02, NDC 10019-638-03, Recall # D-801-2007
CODE
Lots: 3g -- P0424, exp. May 2007; P0436, exp. July 2007. Lot 15g -- P1338, exp March 2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter, New Providence, RI, by letter on March 30, 2007.
Manufacturer: G. C. Hanford Manufacturing Co., Syracuse, NY. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter
VOLUME OF PRODUCT IN COMMERCE
47,314 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

___________________________________
PRODUCT
Sicor Terbutaline Sulfate Injection, USP, 1mg/mL volume in 2 mL vial, Rx only, NDC 0703-1271-04, Recall # D-802-2007
CODE
Lot 06J104, exp. 7/31/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, North Wales, PA, by letters on April 26, 2007.
Manufacturer: Teva Sicor, Irvine, CA. Firm initiated recall is ongoing.
REASON
Product failed specification for pH
VOLUME OF PRODUCT IN COMMERCE
126,475 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT
LADAR6000 Excimer Laser System, Recall # Z-0854-2007
CODE
All serial/lot numbers of the LADAR6000
RECALLING FIRM/MANUFACTURER
Alcon Refractive Horizons, Inc., Orlando, FL, by letter on May 11, 2007. Firm initiated recall is ongoing.
REASON
Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser.
VOLUME OF PRODUCT IN COMMERCE
102 devices
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
a) Ultrasite Horizon Pump IV Set. The product is shipped in cases containing
    24 sets, Recall # Z-0818-2007;
b) Horizon Pump Metriset Burette Set. The product is shipped in cases
    containing 20 sets, Recall # Z-0819-2007
CODE
a) Lot numbers: 60883411 exp 9/09, 60886994 exp 9/09, 60883415 exp 9/09, 60883413 exp 9/09, 60883414 exp 9/09, 60883412 exp 9/09, 60883411 exp 9/09, 60883409 exp 9/09, 60883408 exp 9/09, 60883406 exp 9/09, 60883403 exp 9/09, 60884052 exp 9/09, 60884051 exp 9/09, 60883404 exp 9/09, 60883401 exp 8/09, 60883402 exp 8/09, 60883400 exp 8/09, 60883399 exp 8/09, 60883396 exp 8/09, 60883397 exp 8/09, 60883398 exp 8/09, 60880087 exp 8/09, 60880088 exp 8/09, 60880086 exp 8/09, 60880085 exp 8/09, 60880084 exp 8/09, 60880083 exp 8/09, 60880082 exp 8/09, 60880081 exp 8/09, 60880080 exp 8/09, 60880079 exp 8/09, 60880077 exp 8/09, 60880076 exp 8/09, 60880078 exp 8/09, 60880075 exp 8/09, 60880073 exp 8/09, 60880074 exp 8/09, 60875352 exp 7/09, 60875353 exp 7/09,60875350 exp 7/09, 60875348 exp 7/09, 60875349 exp 7/09, 60875347 exp 7/09, 60876056 exp 7/09, 60875345 exp 7/09, 60875346 exp 7/09, 60875344 exp 7/09, 60875343 exp 7/09, 60875342 exp 7/09, 60873263 exp 7/09, 60873262 exp 7/09, 60873260 exp 7/09, 60873261 exp 7/09, 60871825 exp 6/09, 60871439 exp 6/09, 60871824 exp 6/09, 60871823 exp 6/09, 60871438 exp 6/09, 60871437 exp 6/09, 60871436 exp 6/09, 60871435 exp 6/09, 60871434 exp 6/09, 60871433 exp 6/09, 60871431 exp 6/09, 60871432 exp 6/09, 60871430 exp 6/09, 60878152 exp 6/09, 60871429 exp 6/09, 60869484 exp 6/09, 60869482 exp 6/09, 60869479 exp 6/09, 60861428 exp 6/09, 60869467 exp 6/09, 60869466 exp 6/09, 60861993 exp 5/09, 60861995 exp 5/09, 60861996 exp 5/09, 00VL861992 exp 5/09, 00VL861991 exp 5/09, 00VL861990 exp 5/09, 60872855 exp 5/09, 60861985 exp 4/09, 60872856 exp 5/09, 60872854 exp 5/09, 60861989 exp 5/09 60861987 exp 5/09, 60859835 exp 5/09, 60861986 exp 5/09, 60859834 exp 5/09, 60859832 exp 5/09, 60859831 exp 5/09, 60859830 exp 5/09, 60872648 exp 5/09, 60872649 exp 5/09, 60859829 exp 5/09, 60880072 exp 8/09, 60880071 exp 8/09, 60880070 exp 8/09, 60880069 exp 7/09, 60875361 exp 7/09, 60875359 exp 7/09, 60875360 exp 7/09, 60875358 exp 7/09, 60875357 exp 7/09, 60875354 exp 7/09, 60875351 exp 7/09, 60869478 exp 6/09, 60869480 exp 6/09, 60869477 exp 6/09, 60869474 exp 6/09, 60869472 exp 6/09, 60869475 exp 6/09, 60872863 exp 6/09, 60869473 exp 6/09, 60869471 exp 6/09, 60869470 exp 6/09, 60869468 exp 6/09, 60883303 exp 9/09, 60883302 exp 9/09, 60883300 exp 9/09, 60883296 exp 9/09, 60892342 exp 9/09, 60892341 exp 9/09, 60892340 exp 8/09, 60894050 exp 8/09, 60892339 exp 8/09, 60894049 exp 8/09, 60883293 exp 8/09, 60883294 exp 8/09, 60880023 exp 8/09, 60880022 exp 8/09, 60891081 exp 8/09, 60891082 exp 8/09, 60891080 exp 8/09, 60880021 exp 8/09, 60878211 exp 8/09, 60878210 exp 8/09, 60889215 exp 8/09, 60878209 exp 8/09, 60878207 exp 8/09, 60878206 exp 8/09, 60888274 exp 7/09, 60878205 exp 7/09, 60878201 exp 7/09, 60886694 exp 7/09, 60886695 exp 7/09, 60878200 exp 7/09, 60875237 exp 7/09, 60875236 exp 7/09, 60875234 exp 7/09, 60875235 exp 7/09, 60883723 exp 7/09, 60873265 exp 7/09, 60875233 exp 7/09, 60873264 exp 7/09, 60869494 exp 6/09, 60869495 exp 6/09, 60869493 exp 6/09, 60882489 exp 6/09, 60869491 exp 6/09, 60869489 exp 6/09, 60869488 exp 6/09, 60862067 exp 6/09, 60877549 exp 6/09, 60862066 exp 6/09, 60862065 exp 6/09, 60861761 exp 6/09, 60861760 exp 6/09, 60870771 exp 6/09, 60861759 exp 6/09, 60862063 exp 6/09, 60862064 exp 6/09, 60861758 exp 6/09, and 60861757 exp 5/09;
b) Lot numbers: 60888186 exp 9/11 and 60869008 exp 6/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on April 20, 2007
Manufacturer: B. Braun Dominican Republic, Inc., Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON
Secondary infusion backs up into primary container.
VOLUME OF PRODUCT IN COMMERCE
2,525,709 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02
    (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire).
The devices are comprised of four principal components including the
    ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX of LFX Catheter,
    and the AutoStream Flow Control, Recall # Z-0833-2007;
b) FX Spare Shieldwire Inflators (3.0 - 5.0 mm), Catalog number 60042-02.
  The product is sold 5 per box, Recall # Z-0834-2007;
c) ProGuard Spare Shieldwire Inflators (2.5 - 5.0 mm), Catalog number 61030-01.
    The product is sold 5 per box, Recall # Z-0835-2007
CODE
a) Lot numbers 49709 exp 3/31/07, 51844 exp 5/31/07, 52822 exp 7/31/07,
    53209 exp 5/31/07, 53252 exp 7/31/07, 54264 exp 7/31/07, 54276 exp 11/30/07,
    49912 exp 3/30/07, 50952 exp 5/31/07, 51714 exp 7/31/07, 52488 exp 5/31/07,
    and 54248 exp 11/30/07.
b) Lot numbers 49320 exp 4/30/07, 51710 exp 7/31/07, 52340 exp 8/31/07,
    52884 exp 9/30/07, 53210 exp 10/31/07, and 53614 exp 10/31/07;
c) Lot number 56662 exp 2/28/08
RECALLING FIRM/MANUFACTURER
Kensey Nash Corp., Exton, PA, by telephone on March 26, 2007, and by fax on March 28, 2007. Firm initiated recall is ongoing.
REASON
Insufficient wire sealing
VOLUME OF PRODUCT IN COMMERCE
586 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
a) Custom Fluid Administration Set, Rx only, REF/CAT No.: K09-09209CP,
    Recall # Z-0843-2007;
b) Luer Male Large Bore, REF/CAT No.: 102100001, for use in fluid
    administration sets, 40000, Recall # Z-0844-2007;
c) Custom 72 inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid
    administration sets, Recall # Z-0845-2007;
d) Custom Kit, Cardiac Cath Kit, Rx only, REF/CAT No.: K09-90240HP,
    Recall # Z-0846-2007;
e) Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only,
    Recall # Z-0847-2007
CODE
a) Lot Number F524277;
b) Lot Number F28005;
c) Lot Number F534043;
d) Lot number F534339;
e) Lot number V536479
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by letter on April 17, 2007. Firm initiated recall is ongoing.
REASON
Male luer in fluid administration sets may crack due to inadequate molding process
VOLUME OF PRODUCT IN COMMERCE
41,251 kits
DISTRIBUTION
CA, IL, NJ, and NY
___________________________________
PRODUCT
a) GE Healthcare Innnova 4100/4100 IQ. Digital Fluoroscopic Imaging System
    (Vascular Angiography System), Recall # Z-0869-2007;
b) GE Healthcare Innova 3100/ 3100 IQ Digital Fluoroscopic Imaging System
    (Cardiovascular Imaging System), Recall # Z-0870-2007;
c) GE Healthcare Innova 2100 IQ Digital Fluoroscopic Imaging System
    (Versatile cardiac and vascular), Recall # Z-0871-2007
CODE
a) 80140841 850060707 3016094100 3027444100 4134474100 5094744100 5135844100
    5417684100 6309784100 7028804100 00171VAS01 00490VAS02 082406120016
    082416130020 10091VAS01 190020RX09 201541SP1 251435I12 309672M4100
    314569SJRM12 330489SPEC9 360754INNOVA 386HPOS1 412623LAB1 412623LAB3
    414328INN4100 419696LAB1 530888ANG206 605333RM10 608263XMR
    610954INNOVA41 617525IN1 617636IN1 630275G41 719560INN41 727791INNOVA
    803256SP 804594ANGIO 804764CATH3 812238UN41 813615CL10 816943SP1
    817433HSW4100 843577CL2 845368RM10 904202SP1 904BSSP 915577SP1
    952993INNOVA2 970247INNOVA 972335LIB 972566INNOVA3 A5605732 COR359867
    IL1043VA01 N4192927 NO1015VA04 R4211476 RU1106VA02 UC1129XR33 XF0151
    XF0153 XF0154 XF0155 XF0200 YV0001 YV0002 YV0004 YV0006 YV0007;
b) 3027443100 7022333100 082416030003 082416040015 082416040019 082416120007
    082416120010 082416160008 082416210006 082416220008 082449120007
    214590PH3100 303425CL4 405272SCL2 405840OIC3100 412623LAB2 414647CL1
    415925INV1 480728LAB2 516562INNOVA8 573882UMC1 717782INNOVA31A
    718470INNOVA2 816943STJIC1 816985NKCI 918494IN31A 920169007 A5162256
    A5333035 CS1006VA03 FI1064VA01 M40480151 M4163030 YV0027 YV0028 YV0029
    YV0034 YV0035 YV0037;
c) 83016862101656 00060VAS02 00192VAS04 00282VAS02 00371VAS01 01065VAS01
    082416070006 082416130024 212305CATH1 416480INNOVA 516562INNOVA6
    516562INNOVA7 604682INNOVA1 604682INNOVA2 718470EP 770HMCCL1 781340IN3
    83016102100795 83016242100936 83016802100516 83016802100866 83016802100916
    83016802101197 83016862101656 83016862101916 858554INNOVA2 A4166952 A5164510
    cee15663 HU1205VA01 M2068110 M2569315 M4198195 YV0061 YV0071
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Electric Med Systems LLC, Waukesha, WI, by letter on March 26 & 27, 2007.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, Wisconsin, France. Firm initiated recall is ongoing.
REASON
Measurement errors during the computation of vessel diameters while using the Stenosis Analysis software (also known as Quantitative Coronary Analysis function-QCA) using the auto-calibration function on Innova Digital (located in control room) or in-room InnovaCentral/Touch-Screen.
VOLUME OF PRODUCT IN COMMERCE
144 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Boston Scientific PCNL (Percutaneous Tract) Kit with Nephromax Balloon; Part Number: M0064501110, Recall # Z-0889-2007
CODE
Lot Numbers: 8529320, 8568190, 9371965
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation, Natick, MA, by letter on April 11, 2007.
Manufacturer: Boston Scientific Corporation, Quincy, MA.   Firm initiated recall is ongoing.
REASON
Mislabeled: Outer box unit has correct part number but product is incorrectly identiified as a Percutaneous Tract Kit with Nephromax Balloon. The box actually contains a Percutaneous Tract Kit with Amplatz Dilator and Sheath Kit
VOLUME OF PRODUCT IN COMMERCE
15 kits
DISTRIBUTION
OH, MS, NM, MD, TX and Trinidad
___________________________________
PRODUCT
Sienet MagicStore. Radiological Digital Image Communications System. Model number 7502052, Recall # Z-0890-2007
CODE
Serial numbers 1843, 2635, 2394, 2638, 1920, 2689, 1556, 1968, 1793, 2099, 2632, 2601, 1966, 2055, 2618, 1983, and 2678.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on May 2, 2007.
Manufacturer: Siemens AG MED, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
System could crash and result in data loss.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
CA, CO, FL, MS, NH, NJ, NY, and WA

END OF ENFORCEMENT REPORT FOR JUNE 6, 2007

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