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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.
January 2, 2008
08-01
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Minnie's Bake Shop Chocolate Chunk Cookies, 7 oz. (198g). Contains: Wheat, Soy, Egg and Milk. Allergy Warning: Manufactured on shared equipment with peanuts and/or tree nuts, Recall # F-101-8
CODE
Best if used by March 2008
RECALLING FIRM/MANUFACTURER
Dairy State Foods Inc, Glendale WI, by press release on October 12, 2007. Firm initiated recall is ongoing.
REASON
A limited quantity of 7 oz. Minnie's Bake Shop Chocolate Chunk Cookies may contain undeclared macadamia nuts. People who have an allergy to macadamia nuts run the risk of serious or life-threatening allergic reaction if they consume these products.
VOLUME OF PRODUCT IN COMMERCE
1298 packages
DISTRIBUTION
FL
___________________________________
PRODUCT
Lochmead Farms Chocolate Country Fresh Premium Ice Cream Half Gallon in round cardboard carton, Recall # F-102-8
CODE
Code of June 22, 2008 stamped on the bottom of the container.
RECALLING FIRM/MANUFACTURER
Lochmead Dairy, Inc. Junction City, OR, by e-mail and telephone on October 11, 2007 and by press release on October 15, 2007. Firm initiated recall is complete.
REASON
Some containers actually contain a different product; Lochmead Farms brand Country Fresh Rocky Road Premium Ice Cream, which has almonds. The Chocolate ice Cream label does not list almonds as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
952 containers
DISTRIBUTION
OR
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Baclofen Tablets USP, 10 mg, 100 (10X10) unit dose tablets per package, Rx only, NDC 68084-038-01, Recall # D-080-2008
CODE
Lot 063789, exp. 11/30/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services Corp, Columbus, OH, by letter dated November 27, 2007.
Manufacturer: Watson Laboratories, Inc., Corona, CA. Firm initiated recall is ongoing.
REASON
Product may not meet dissolution specification over shelf life.
VOLUME OF PRODUCT IN COMMERCE
1,501/100-tablet packages
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-0424-08;
b) Blood and Blood Products for Reprocessing - Recovered Plasma, Recall # B-0425-08
CODE
a) and b) Unit: 55S55386
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by letter and e-mail on February 12, 2007. Firm initiated recall is complete.
REASON
Blood product collected from a donor with a gender discrepancy on his registration card, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR and CA
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Ellex, Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-scan modality, Recall # Z-0148-2008
CODE
Serial numbers: V305-00510 V307-18205 V307-18405 V307-20309 V307-20409
V307-20609 V307-20809 V307-20909 V307-21409 V307-19605 V307-15703
V307-16404 V307-16504 V307-19805 V307-17304 V307-18105 V307-19105
V307-14303 V306-09910 V307-13902 V306-05705 V307-17104 V307-17004
V307-14203 V307-14903 V307-17502 V307-15203 V307-18305 V307-15503
V306-04605 V307-18905 V307-16003 V307-18605 V307-18004 V307-16904
V307-21009 V307-14803 V307-20005 V307-17904 V307-19505 V307-12302
V307-21109 V307-21509 V307-11101 V307-19305 V307-21209 V307-17404
V307-18705 V307-18505 V307-16304 V306-07108 V306-09209 V306-04405
V306-06408 V307-19205 V307-20209 V307-19005 V306-12104 V307-19905
RECALLING FIRM/MANUFACTURER
Ellex, Inc., Sacramento, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
REASON
Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations. Incorrect IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan enabled Version 3.0.0 software can cause incorrect IOL calculations.
VOLUME OF PRODUCT IN COMMERCE
59 systems
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Vortex® VX, Port System, 9.6FR, REF/Part Number: P5455K, Catalog Number: P5455, Latex Free, Sterile, Recall # Z-0149-2008
CODE
Lot #: 30938
RECALLING FIRM/MANUFACTURER
Rita Medical Systems, Inc., Manchester, GA, by letters beginning on October 3, 2007 and October 9, 2007. Firm initiated recall is ongoing.
REASON
The product may contain an incorrect size catheter.
VOLUME OF PRODUCT IN COMMERCE
150 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Precept Medical Products, Tape Fog Shield Surgical Mask Green Fiberglass Free,
Reorder #: 65-3322, non-sterile, 50/box, 5 box/case, Recall #: Z-0153-2008;
b) Precept Medical Products, Foam Fog Shield Surgical Mask Green Fiberglass Free,
Reorder #: 65-3320, non-sterile, 25/box, 6 box/case, Recall # Z-0154-2008
CODE
a) Lot Numbers: 1053430 through 1061090, and 1060180, 1060190, 1060200, 1060230,
1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060440,
1060450, 1060460, 1060470, 1060480, 1060510, 1060520, 1060530, 1060660,
1060670, 1060680, 1060970, 1061000, 1061240, 1061250, 1061350, 1061360,
1061370, 1061390, 1061420, 1061440, 1061450, 1061530, 1061560, 1061570,
1061580, 1061590, 1061630, 1061640, 1061650, 1061670, 1061710, 1071720,
1061730, 1061790, 1061800, 1061810, 1061840, 1061850, 1061860, 1061870,
1062010, 1062020, 1062060, 1062070, 1062090, 1062120, 1062130, 1062190,
1062200, 1062210, 1062220, 1062360, 1062370, 1062390, 1062400, 1062440,
1062470, 1062510, 1062540, 1062560, 1062570, 1062580, 1062690, 1062700,
1062710, 1062720, 1062760, 1062770, 1062780, 1062790, 1062820, 1062850,
1062860, 1062890, 1062900, 1062910, 1062970, 1062980, 1063030, 1063040,
1063050, 1063060, 1063180, 1063190, 1063200, 1063260, 1063270, 1063280,
1063290, 1063330, 1063390, 1063400, 1063410, 1063420, 1063430, 1063450,
1063460, 1063470, 1063480, 1063500, 1070080, 1070090, 1070110, 1070120,
1070290, 1070300, 1070310, 1070320, 1070460, 1070470, 1070500, 1070510,
1070520, 1070530, 1070540, 1070600, 1070640, 1070650, 1070660, 1070850,
1070860, 1070870, 1070880, 1071000, 1071310, 1071430, 1071440, 1071450,
1071460, 1071480, 1071490, 1071500, 1071510, 1071520, 1071530, 1071550,
1071620, 1071650, 1071660, 1071670, 1071690, 1071700, 1071710, 1071720,
1071730, 1071740, 1071760, 1071770, 1071780, 1071790, 1071810, 1071830,
1071840, 1071850, 1071860, 1071870, 1071880, 1071900, 1071920, 1071930,
1071940, 1071950, 1071970, 1071980, 1071990, 1072000, 1072050, 1072060,
1072070, 1072080, 1072110, 1072120, 1072130, 1072180, 1072190, 1072200,
1072230, 1072250, 1072260, 1072350, 1072400, 1072410, 1072420, 1072460,
1072470, 1072480, 1072490, 1072500, 1072530, 1072540, 1072550, 1072560,
and 1072570, and Lot Numbers 1062207 through 1071147 (only those lots in this
range with the last digit of "7" (seven));
b) Lot Numbers: 1060800 through 1060890, 1060170, 1060180, 1060190, 1060200,
1060230, 1060240, 1060250, 1060260, 1060270, 1060300, 1060310, 1060320,
1060330, 1060340, 1060380, 1060390, 1060400, 1060410, 1060440, 1060450,
1060460, 1060470, 1060510, 1060520, 1060530, 1060540, 1060580, 1060590,
1060600, 1060610, 1060620, 1060650, 1060660, 1060670, 1060680, 1061170,
1061530, 1061560, 1061720, 1071730, 1061790, 1061880, 1061990, 1062000,
1062010, 1062070, 1062080, 1062230, 1062260, 1062270, 1062400, 1062410,
1062420, 1062470, 1062480, 1062540, 1062550, 1062560, 1062620, 1062630,
1062680, 1062690, 1062700, 1062760, 1063310, 1063320, 1063330, 1063340,
1063380, 1063390, 1070250, 1070260, 1070270, 1070330, 1070340, 1070360,
1070370, 1071370, 1071380, 1071420, 1071520, 1071590, 1071870, 1072010,
1072090, 1072140, 1072150, 1072180, 1072210, 1072220, 1072290, 1072300,
1072370, 1072390, 1072580
RECALLING FIRM/MANUFACTURER
Recalling Firm: Precept Medical Products, Inc., Arden, NC, by letters on September 14, 2007 and October 4, 2007.
Manufacturer: Precept Medical Products Inc, Childersburg, AL. Firm initiated recall is ongoing.
REASON
Small slits under the folds of the masks; thus they may not provide the protection necessary between the patient and surgical staff.
VOLUME OF PRODUCT IN COMMERCE
11,546,350
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch
plastic binder, Recall # Z-0192-2008;
b) Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087,
and LIT (DRAFT) Medtronic, Recall # Z-0193-2008;
c) Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0194-2008;
d) Medtronic Sofamor Danek, 10 mm Satellite Sphere CoCr, Size 10 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0195-2008;
e) Medtronic Sofamor Danek, 11 mm Satellite Sphere CoCr, Size 11 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0196-2008;
f) Medtronic Sofamor Danek, 12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0197-2008;
g) Medtronic Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0198-2008;
h) Medtronic Sofamor Danek, 14 mm Satellite Sphere CoCr, Size 14 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0199-2008;
i) Medtronic Sofamor Danek, 15 mm Satellite Sphere CoCr, Size 15 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0200-2008;
j) Medtronic Sofamor Danek, 16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1
each, Material Cobalt Chrome, Sterile, Rx only, Recall # Z-0201-2008;
k) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0202-2008;
l) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 11 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0203-2008;
m) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 12 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0204-2008;
n) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 13 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0205-2008;
o) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0206-2008;
p) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 15 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0207-2008;
q) Medtronic Sofamor Danek, Satellite System Sphere PEEK, Size 16 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only, Recall # Z-0208-2008;
r) Medtronic Sofamor Danek, 8 mm Curette, size 8 mm, Material Stainless Steel/Radel,
quantity 1 each, Non-sterile, Rx only, Recall # Z-0209-2008;
s) Medtronic Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel,
quantity 1 each, Non-sterile, Rx only, Recall # Z-0210-2008
CODE
a) All manuals; the manuals were not coded;
b) All (US versions) guides/techniques; The Surgical Technique and Manual are not
coded;
c) All Lots to include: W05K0556, W05K1614, W06A3260;
d) All Lots to include: W05K0134, W05K0543, W05K0560, W05K0565,
W05K1572, W05K1573, W05K1575;
e) All Lots to include: W05K0144, W05K0552, W05K0553, W05K0554,
W05K0567, W05K0572, W05K0722;
f) All Lots to include: W05K0541, W05K0542, W05K0550, W05K0551,
W05K0558, W05K0731, W06A0842;
g) All Lots to include: W05K0132, W05K0557, W05K1576, W05K1595,
W05K2449, W06A0915;
h) All Lots to include: W05K0561, W05K0582, W05K1920, W06A2074,
W07H0210;
i) All Lots to include: W05K0562, W05K0566, W05K1593, W06A2809;
j) All Lots to include: W05K0135, W05K0564, W05K1016, W06A1100;
k) All Lots to include: LX52, MA67;
l) All Lots to include: LX53, LX59, MG73, MY47, MY49, NC36, ND61, NE27;
m) All Lots to include: LX54, LX60, MA68, MG74, NB26, NE28, NF61;
n) All Lots to include: LX55, LX61, MA69, MG75, NB27, ND62, NE29, NF62;
o) All Lots to include: LX56, LX62, MA70, MG76, NB28, ND63, NE30q);
p) All Lots to include: LX57, LX63, MA71, MG77, NB29, NE31;
q) All Lots to include: LX58, MA72, MA98, MY48, NB30, NE32;
r) All Lots to include: NM04H015, NM04H015Z, NM04H031, NM04J023,
NM04J0231;
s) ALL LOTS to include: NM04H0021, NM04H0051, NM04H005Z, NM04H0321
RECALLING FIRM/MANUFACTURER
Medtronic Sofamor Danek USA Inc, Memphis, TN, by e-mail on September 12, 2007, by hand delivery on September 13, 2007 and by letter dated October 25, 2007. Firm initiated recall is ongoing.
REASON
Marketed without approval: The surgical technique includes reference to an 8mm Trial and 8mm Curette, while the cleared -510 (k)- device only includes spheres between 9.5 and 19 mm.
VOLUME OF PRODUCT IN COMMERCE
200 to 300 manuals, 1,140 instruments and implants
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
HUDSON RCI®, Variable Concentration, Large Volume Nebulizer, Catalog Number (REF) 1770 and 41770, Rx Only, Recall # Z-0211-2008
CODE
Lot Numbers: 49069, 50069, 51069, 52069, 53069, 01079, 02079, 03079, 04079, 06079, 12079, 1279R, 13079, 15079, 16079, 17079, 17079R, 18079, 19079, 19079R and 20079; and Lot Numbers: 50069, 52069, 01079, 06079, 16079, 17079, 17079R, and 18079
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Creek Dr. Durham, NC, by letter on/about August 22, 2007.
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico. Firm initiated recall is ongoing.
REASON
Decreased in flow output; through the nebulizer - (when used at higher oxygen concentration settings, this decrease in flow, may lower the oxygen concentration inspired by the patient).
VOLUME OF PRODUCT IN COMMERCE
215656 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer,
Recall # Z-0312-2008;
b) COULTER LH780 Analyzer, Part Number: 723585, Hematology analyzer,
Recall # Z-0313-2008;
c) COULTER LH 500 Series System, Part Number: 178833, Hematology analyzer,
Recall # Z-0314-2008;
d) COULTER GEN*S System, Part Number: 6605381, Hematology analyzer,
Recall # Z-0315-2008
CODE
All software versions
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc, Brea, CA, by letters on April 18, 2007.
Manufacturer: Beckman Coulter, Inc., Miami, FL. Firm initiated recall is ongoing.
REASON
Patient Mis-identification can occur: 1) - When a positive identifier (Sample ID or Cassette/Position) is manually edited to a positive identifier that is already in the To Do list. The workstation will accept the entry and no error message will be generated, creating 2 samples with the identical positive identifier.
2) - When manually entering a Patient ID, if a blank space is entered between the characters in the Patient ID field, the system will only accept the characters before the space.
VOLUME OF PRODUCT IN COMMERCE
3,973 units in the US; 321 units in Canada
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe),
Recall # Z-0318-2008;
b) Biomet Optigun Cement Gun, Ratchet, non-sterile; REF 419500 and REF 4195
(in Europe), Recall # Z-0319-2008
CODE
a) All units, including lots 105300, 007602, 011900, 014300, 014900, 103500, 209700,
219100, 232000, 306900, 331600, 520800, 526200, 610000, 619600, 644100,
007600, 007601, 007603, 007604, 011900, 014300, 014900, 014901, 020700,
024100, 103500, 105300, 109004, 123100, 206100, 209700, 219100, 228600,
229200, 232000, 306900, 307000, 317200, 322800, 331600, 403800, 406800,
411200, 411300, 413100, 415000, 418200, 421100, 423900, 429200, 432300,
437300, 443200, 503700, 506800, 511200, 520800, 526200, 545200, 552000,
644100, 645700, 645800, 708600, 708700 and 999999;
b) All units including lots 429900, 642100 and 647700
RECALLING FIRM/MANUFACTURER
Biomet, Inc. Warsaw, IN, by letter dated September 21, 2007. Firm initiated recall is ongoing.
REASON
Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.
VOLUME OF PRODUCT IN COMMERCE
6,590 units
DISTRIBUTION
Nationwide, Canada and Japan
___________________________________
PRODUCT
a) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can
run on all Gemini TFs, GXLs and EBW Workstations. (The product is a software
application that is installed in Philips Medical System CT scanners.), Recall #
Z-0366-2008;
b) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can
run on all Brilliance CT scanners using software versions 2.0 through V 2.2.5 and all
EBW workstations using software versions 2.0 through V3.5.2. (The product is a
software application that is installed in Philips Medical System CT scanners.)
Recall # Z-0367-2008
CODE
For 16 slice, 16 slice Big Bore, 40 slice, and 64 slice Brilliance CT scanners the affected software application versions are: 2.0, 2.0.2, 2.2, 2.2.1, 2.2.2, and 2.2.5. For Extended Brilliance Workspace the affected software application versions are: 2.0.0, 2.0.1, 2.0.50, 2.1.0, 3.0.0, 3.0.1, 3.0.2, 3.5, and 3.5.2
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter on September 10, 2007. Firm initiated recall is ongoing.
REASON
Incorrect Measurement: Incorrect measurement will occur when the operator uses the distance or area measurement function, such as Graphic Tool line or ROI on zoomed and batch saved images from the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or on a PACS System.
VOLUME OF PRODUCT IN COMMERCE
2,544 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
a) Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi,
COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry analyzers;
Catalog No. 20751995190, Recall # Z-0377-2008;
b) Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in conjunction with
Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical chemistry
analyzers; Catalog No. 20752401190, Recall # Z-0378-2008;
c) Roche Ammonia/Ethanol/CO2 Control A (Abnormal) for use in conjunction with
Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical
chemistry analyzers; Catalog No. 20753009190, Recall # Z-0379-2008;
CODE
a) Lot No: 179070-01 and 179070-02; exp. 4/30/2008;
b) Lot No: 178993-01 and 178993-02; exp. 3/31/2008;
c) Lots No: 179021-01 and 179021-02; exp. 3/31/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter on November 14, 2007.
Manufacturer: Microgenics Corp., Fremont, CA. Firm initiated recall is ongoing.
REASON
High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
VOLUME OF PRODUCT IN COMMERCE
4,011 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number: 0691P; ARCC 0427; Exp 2008-9; (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P), Recall # Z-0456-2008
CODE
Lot No. : 691295
RECALLING FIRM/MANUFACTURER
Microbiologics, Inc., Saint Cloud, MN, by telephone and letter on October 17, 2007. Firm initiated recall is ongoing.
REASON
Mislabeled: DuoPacks of Proteus vulgaris contained Listeria monocytogenes instead of the labeled Proteus vulgaris.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) Life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium;
Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Part #: 7L877,
Recall # Z-0523-2008
b) Life+cel, Replacement battery for Cardiac Science FirstSave Survivalink, Lithium
Sulfur Dioxide, Voltage 12V, 7.5 Amps, OEM P/N: 9141-001, Part Number: 2L561,
Recall # Z-0524-2008
CODE
a) All Replacement batteries;
b) All Batteries
RECALLING FIRM/MANUFACTURER
BatteryZone, Inc., Somerset, NJ, by letters on September 3, 2007 and letter dated October 25, 2007. Firm initiated recall is ongoing.
REASON
Marketed without 510 (K) approval.
VOLUME OF PRODUCT IN COMMERCE
118 batteries part # 2L561; 24 batteries Part # 7L877
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm,
Catalog Number: A000137000, Recall # Z-0533-2008
b) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm,
Catalog Number: A000138000, Recall # Z-0534-2008
c) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm,
30mm connector, Catalog Number: A137001000, Recall # Z-0535-2008
d) Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve Spare Part,
Catalog Number: A137000501, Recall # Z-0536-2008
CODE
a) Lot Numbers: 000026, 000037, 000097, 010026, 010077, 020006, 020026, 030046,
040016, and 020095;
b) Lot Number: 010017;
c) Lot Numbers: 030046, and 040056;
d) Lot Number: 030005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ambu Inc, Glen Burnie, MD, by letters dated August 21, 2007 and November 29, 2007.
Manufacturer: Ambu A/S, Ballerup, Denmark. Firm initiated recall is ongoing.
REASON
Lower pressure than expected: Medical device for respiratory care may leak and not register accurate flow settings that affect patient respiration.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide
END OF ENFORCEMENT REPORT FOR JANUARY 2, 2008
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