 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
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.
April 30, 2008
08-18
___________________________________
PRODUCT
Soup - Boston Market Classic Minestrone Soup in 23 oz. plastic container with a cardboard sleeve printed with the Boston Market logo, Recall # F-286-8
CODE
Enjoy By 03/08/08
RECALLING FIRM/MANUFACTURER
The Harris Soup Company, Portland, OR, by telephone on February 29, 2008. Firm initiated recall is ongoing.
REASON
Product labeled as Minestrone Soup actually contains Chicken Tortilla Soup with soy lecithin as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
1,890 containers
DISTRIBUTION
CA, NV
__________________________________
PRODUCT
Food For Life Spelt Bread, UPC 0 73472 00168 4, sold frozen in a 24 oz. (680g) light blue package and bears either of the two following descriptions: Food For LIfe, Wheat Alternative Spelt Bread or Food For Life, Fruit Juice Sweetened Spelt Bread *** The bread product is packaged in a 24 oz. (680g) unit clear plastic bag with light blue, dark blue, orange, white and yellow preprinted labeling with a green quick lock bag closure. The product shipped in a kraft cardboard box (case) with a single orange label adhered to the exterior of the box. The orange label identifies the bread product case as Wheat-Alternative Spelt Bread or Fruit Juice Sweetened Spelt Bread. There are 6 unit bags per case, Recall # F-290-8
CODE
Lot Codes: H1847, H2042, H2136, H2435, H2872, H2974, H3224, H3460, I0485
RECALLING FIRM/MANUFACTURER
Food For Life Baking Co Inc., Corona, CA, by press release on March 18, 2008 and by letters on March 18 and 19, 2008. Firm initiated recall is ongoing.
REASON
The products contain Spelt flour which is considered to be wheat. However, the firm failed to declare the product as "Contains Wheat" on the product label.
VOLUME OF PRODUCT IN COMMERCE
2,241 cases/ 6 loaves/case
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fresh bread loaves, labeled "HONEY SPELT BREAD" Net Wt. 18 oz. Product is packaged in individual flexible plastic bags packed under Islands Bakery brand, Recall # F-291-8
CODE
Pull dates of "03 31", "04 01", "04 02", "04 03", and "04 04". The code is put on a white sticker and placed on the bread bag.
RECALLING FIRM/MANUFACTURER
Newman Foods Inc., Arlington, WA, by on site visit and letter starting on March 29, 2008. Firm initiated recall is complete.
REASON
Product contains spelt flour but does not list wheat as an ingredient and also states incorrectly that it contains no wheat flour.
VOLUME OF PRODUCT IN COMMERCE
412 loaves
DISTRIBUTION
WA
__________________________________
PRODUCT
Bibi Rainbow DISFRUTA-ME***Plastic bottle with chewing gum confection assorted
flavors, 12 piezas pieces, Fecah Elab.***Cont. Net. 264 g (22g c/u) Net. Wt. 9.3 oz
(0.77 oz each), Recall # F-297-8;
b) Miguelito Azucar Salada Enchilada & Acidulada, Mexican Candy, 1.7 oz./5 grams;
Product of Mexico, Recall # F-298-8
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Villa Mex Imports, Inc., San Antonio, TX, by telephone and letters pn January 3, 2008 and by fax and letters on January 13, 2008.
Manufacturer: Fabrica De Dulces Miguelito S.A. De C. V., Mexico City, Mexico. Firm initiated recall is ongoing.
REASON
Product contains excessive amounts of lead.
VOLUME OF PRODUCT IN COMMERCE
288 cases
DISTRIBUTION
TX
___________________________________
PRODUCT
Wu Hua Cha Instant Tea Beverage; 6.5 oz. (184 g). Product of China, Recall # F-287-8
CODE
5566437 5565489 1405
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prosperity Resources International Inc., Irvington, NJ, by press release, letters and telephone on January 23, 2008.
Manufacturer: Hua Tai Food Co., Ltf, Guangdong, China. Firm initiated recall is complete.
REASON
FDA sampled the product and found it to contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
5 cartons (48 x 6.5 oz. packets)
DISTRIBUTION
MD, NC and NY
___________________________________
PRODUCT
Coconut flake labeled as "PCC natural" brand, "Earth House Foods" brand, and "Central Co-op's Madison Market Natural Foods" brand, all sold in 8 oz plastic bags. Recall # F-288-8
CODE
All product codes produced
RECALLING FIRM/MANUFACTURER
R & K Foods Inc., Seattle, WA, by e-mail on February 1, 2008. FDA initiated recall is complete.
REASON
Product contains undeclared sulfites based on FDA’s analysis.
VOLUME OF PRODUCT IN COMMERCE
190 - 8 oz packages
DISTRIBUTION
WA
__________________________________
PRODUCT
Kuner's Sliced Sweet Pickled Beets, Net Wt 16 oz (1 lb), Ingredients: Beets, Water, Sugar, High Fructose Corn Syrup, Vinegar, Spice, Salt, Recall # F-289-8
CODE
EGAA8317/003 045
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lakeside Foods, Inc., Manitowoc, WI, by letter on April 15, 2008
Manufacturer: Lakeside Foods, Inc., Belgium, WI, Firm initiated recall is ongoing.
REASON
The firm received foreign material complaints (large glass particles) found in the brine of Sliced Pickled Beets in 16 oz jars.
VOLUME OF PRODUCT IN COMMERCE
1250 cases (12 jars per case)
DISTRIBUTION
CO, MT, NE, NM, SD, UT
___________________________________
PRODUCT
a) Soy yogurt Cinnamon Bun flavor. Packaged in 6 oz. plastic containers with lid,
12 cups per case. Label includes: All Natural So Delicious Dairy Free Cinnamon Bun
6 oz (170g), Recall # F-292-8;
b) Soy yogurt Blueberry flavor. Packaged in 6 oz. plastic containers with lid, 12 cups
per case. Label includes: All Natural So Delicious Dairy Free Blueberry 6 oz (170g),
Recall # F-293-8;
c) Soy yogurt Peach flavor. Packaged in 6 oz. plastic containers with lid, 12 cups per
case. Label includes: All Natural So Delicious Dairy Free Peach 6 OZ (170g),
Recall # F-294-8;
d) Soy yogurt Raspberry flavor. Packaged in 6 oz. plastic containers with lid, 12 cups
per case. Label includes: All Natural So Delicious Dairy Free Raspberry 6 oz (170g)
Recall # F-295-8;
e) Soy yogurt Vanilla flavor. Packaged in 6 oz. plastic containers with lid, 12 cups per
case. Label includes: All Natural So Delicious Dairy Free Vanilla 6 oz (170g),
Recall # F-296-8;
CODE
a) "41-37 F-2R(L)": 41-37 is the plant code: F is the Line number and 2R(L) is the row
designation; Best Before Dates: "4-11-08", "4-18-08", and "5-02-08";
b) "41-37 F-2R(L)": 41-37 is the plant code: F is the Line number and 2R(L) is the
row designation; Best Before Dates: "4-11-08", "4-18-08", and "5-02-08";
c) "41-37 F-2R(L)": 41-37 is the plant code: F is the Line number and 2R(L) is the
row designation; Best Before Dates: "4-11-08", "4-18-08", and "5-02-08";
d) "41-37 F-2R(L)": 41-37 is the plant code: F is the Line number and 2R(L) is the
row designation; Best Before Dates: "4-11-08", "4-18-08", and "5-02-08";
e) "41-37 F-2R(L)": 41-37 is the plant code: F is the Line number and 2R(L) is the
row designation; Best Before Dates: "4-11-08", "4-18-08", and "5-02-08"
RECALLING FIRM/MANUFACTURER
Turtle Mountain Inc., Eugene, OR, by telephone and letter on April 8, 2008. Firm initiated recall is ongoing.
REASON
Product may be contaminated with mold.
VOLUME OF PRODUCT IN COMMERCE
70,728 cups total
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Atenolol and Chlorthalidone tablets, USP, 50/25 mg, bottles of 100, Rx only, NDC 0904-7881-60, Recall # D-158-2008
CODE
Lot L-1456, Exp. 08-09
RECALLING FIRM/MANUFACTURER
Legacy Pharmaceutical Packaging LLC, Earth City, MO, by letter on March 14, 2008. Firm initiated recall is ongoing.
REASON
Mislabeled; bottles labeled as Atenolo/Chlorthalidone Tablets 50mg/25mg actually contain Gabapentin 100 mg.
VOLUME OF PRODUCT IN COMMERCE
4,778/100-tablet bottles
DISTRIBUTION
MI
__________________________________
PRODUCT
Etomidate Injection 20mg (2mg/mL), Sterile, nonpyrogenic, 10mL Single-Dose Vials, packaged in cartons of 10 vials, --- NDC 55390-762-10, Recall # D-200-2008
CODE
Lot #957881, Exp. Date 06/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bedford Laboratories, Bedford, OH, by letters on March 24, 2008.
Manufacturer: Ben Venue Laboratories Inc., Bedford, OH. Firm initiated recall is ongoing.
REASON
Subpotent; 12month stability
VOLUME OF PRODUCT IN COMMERCE
97,290 20mg/10mL vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Carbamazepine Tablets USP (Chewable), 100 mg, Rx, in bottles of 100 Tablets, NDC 51672-4041-1, and 500 Tablets, NDC 51672-4041-2, Recall # D-201-2008
CODE
Lots 078198, 078335, 078336 (exp. 7/2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letters on March 28, 2008.
Manufacturer: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel, Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirement.
VOLUME OF PRODUCT IN COMMERCE
26,008 bottles
DISTRIBUTION
Nationwide and Puerto Rico
___________________________________
PRODUCT
Red Yeast Rice, Dietary Supplement, 600 mg potency, 60-capsule bottles, UPC 033674155172 and 120-capsule bottles, UPC 033674155400, Recall # D-202-2008
CODE
60-Capsule Bottles: Lots 509859, exp. 10/31/08; 514596, exp. 1/31/09; 522011, exp. 5/31/09; 528163, exp. 10/31/09; 530491, exp. 11/30/09; 120-Capsule Bottles: Lots 504570, exp. 6/30/08; 507169, exp. 8/31/08; 511280, exp. 10/31/08; 514341, exp. 1/31/09; 518847, exp. 1/31/09; 520928, exp. 4/30/09; 524941, exp. 8/31/09; 525251, exp. 8/31/09; 528162, exp. 10/31/09; 531608, exp. 11/30/09
RECALLING FIRM/MANUFACTURER
Nature's Way Products Inc., Springville Utah, by letter on March 31, 2008. FDA initiated recall is ongoing.
REASON
Product contains excessive levels of lovastatin.
VOLUME OF PRODUCT IN COMMERCE
74,859 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Human Corneal tissue for Transplant, Recall # B-1085-08
CODE
14330701 and 14330702
RECALLING FIRM/MANUFACTURER
The North Carolina Eye Bank, Inc., Winston Salem, NC, by telephone on October 12, 2007. Firm initiated recall is complete.
REASON
Eye tissue(s) that were mislabeled (in that an appropriate specimen for RPR testing was not used), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
TX
___________________________________
PRODUCT
ACUSON Sequoia Diagnostic Ultrasound System, general purpose Diagnostic Ultrasound system, a) Material Number 8245875; b) Material Number 8246951;
c) Material Number 8267697; Recall Z-0661-2008
CODE
a) Serial Numbers: 54602 56482 55620 53997 51959 56156 56192 56040 53614 56483 56651 56526 60018 60247 60348 60835 60870 60339 56577 53519 62170 59126 62257 60258 62370 63164 54043 63929-1 55706 56104 56124 56654 56922 57303 57380 57494 59024 59131 59174 59176 59221 60054 60057 60228 60237 60251 60254 60282 60285 60338 60438 60450 60460 60461 60601 60620 60625 60631 60633 60634 60645 60647 60661 60728 60860 60875 60880 60947 61043 61053 61067 61108 61114 61118 61120 61121 61123 61127 61212 61221 61225 61290 61422 61544 61661 61673 61745 61751 61771 61974 62040 62053 62057 62116 62128 62130 62132 62233 62240 62282 62396 62431 62543 62644 62738 62764 62790 62838 62840 62861 62871 62916 62924 63023 63097 63101 63103 63114 63115 63146 63165 63184 63196 63203 63205 63208 63337 63366 63368 63389 63408 63420 63455 63462 63468 63470 63566 63573 63690 63856 63862 63867 63878 63885 63886 63899 63928 64051 50970 51577 52356 52448 52565 52732 52743 52770 53437 53712 53725 54223 54549 54937 55091 55092 55156 55272 55734 54640 55197 53060 54446 54254 54423 54766 52071 52110 52427 53011 55012 54686 51080 52076 53357 54552 53467 54380 54688 52959 53932 52034 54121 52051 53446 50447 50834 50975 51048 51073 51571 52865 53252 53626 53631 53643 53844 53950 54065 54123 54317 54389 54521 54529 54546 54603 54934 54949 55082 55104 55135 55140 55441 55461 55838 55895 56355 57017 55351 55244 54315 54199 54366 51648 53978 51023 54489 54536 54808 50140 54130 53579 55553 50194 55853 53590 55477 53524 54958 63546 56823 56717 56758 56786 56196 55713 56123 56247 56248 56625 62755 50235 54425 53244 53803 50228 53182 54361 and 53990;
b) Serial Numbers: 62519 62835 63108 56191 and 54332;
c) Serial Numbers: 63168 61316 62848 63188 63275 and 63727
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Mountain View, CA, by letter on September 25, 2007. Firm initiated recall is ongoing.
REASON
Measurement Error affecting all Sequoia systems using the PAL video standard configuration and have a perspective PC installed: 1) The Sequoia" system is operating at a software revision below 8.0. 2) The Sequoia" system is configured to PAL video mode (normal for systems running at 240V 50 Hz.). 3) While using any of the Perspective" advanced display options listed above, an image or clip is then stored or saved to the system hard drive, MOD or a storage device. (This image or clip is known as a secondary capture.). 4) The secondary capture images/clips are subsequently recalled for review and measurements are made. If a measurement is taken on these secondary capture images/clips, an error can occur. The error is 0% if taken in the same axis that calibration was performed, and ranges proportionately up to 9% if the measurement is taken orthogonal or at right angles (90 degrees) to the axis that was used for calibration. If calibration was done on the horizontal axis, then vertical measurements are underestimated. If calibration was done on the vertical axis, then horizontal measurements are overestimated.
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) BIPAP AUTO, CORE PACKAGE NA, model number 1017442, filter, mask,
and/or accessories for sleep therapy and ventilation devices, Recall # Z-1055-2008;
2) Filters under the following brand names: a) filter std incoming 7100 CPAP qty 1
model number 1039618; b) filter reusable PLV 2/pkg model number 35220;
c) LX UL Fine Filter 2 pack model number 1006193;
d) RP-M Series Ultrafine Filters 6 pack model number 1029331;
e) RP Vision OM Reg Filter (ASCO) model number 1007547;
and f) REPL Filters package of 4 model number 929-4. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1056-2008;
3) Non-continuous ventilator accessories under the following brand names:
a) Adult ECG Electrodes model number 1016360;
b) O2 Enrichment Attachment BX 10 model number 312010;
c) O2 Enrichment Attachment Single model number 312710;
d) Alice 5, Domestic model number 1017226;
e) BIPAP Auto M.W/Humid, W/SmartCard, CA model number CA701HS;
f) BIPAP Auto M.W/Humid, W/SmartCard, US model number DS700HS;
g) BIPAP Auto M, W/SmartCard, US model number DS700S;
h) BIPAP Auto SV W/SmartCard Dom Core model number 1040716;
i) BIPAP Harmony, Intl model number 1012823;
j) BIPAP Plus M, US model number DS600;
k) BIPAP Plus M, W/Humid US model number DS600H;
l) BIPAP S/T Core Pkg NA model number 1014248;
m) BIPAP S/T North America model number 1012885;
n) BIPAP Vision Filter Pack model number 582101;
o) Duet LX/BIPAP Pro/Synch Pollen QTY 1 model number 1039611;
p) FLXTB, 5 ½ inch STD, 22 mm, CE model number 1006042;
q) FLXTB, 6 in Trach 15 mm taper, CE model number 1004968;
r) GP UL-Fine Filter 2 pack model number 1006190;
s) Incoming Filter 7000, 7001 CPAP model number 7070;
t) Infant ECG Electrodes model number 1016361.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1057-2008;
4) Inv Circuit Assembly Box 10 CE model number 652002. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1058-2008;
5) M Series Heated Humidifier Domestic model number 1022257. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1059-2008;
6) Mouthpiece, Angled 22mm CE model number FC06566. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1060-2008;
7) Omni Lab Core Domestic model number 1043343. Filter, mask, and/or accessories
for sleep therapy and ventilation devices, Recall # Z-1061-2008;
8) PLV-102, 100V 50/60 HZ Japanese model number 87006. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1062-2008;
9) Power Cord Accessory under the following brand names: a) Power Cord W/C7 End
Europe 5 ft model number 1039014 and b) Power Cord W/C7 End USA/CAN model
number 1005894. Filter, mask, and/or accessories for sleep therapy and ventilation
devices, Recall # Z-1063-2008;
10) Non-continuous ventilators accessories under the following brand names:
a) REM Auto M. w/Humid, w/Smartcard A Flex US model number DSS10HS;
b) REM Auto M. w/SC, w/Humid A Flex CAN model number CA511HS. Filter,
mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1064-2008;
11) Non-continuous ventilator accessories under the following brand names:
a) REMStar (Tower) Ultrafine Qty 1 model number 1036915,
b) REMStar Auto M. w/Humid. w/Smartcard. US model number DS500HS;
c) REMStar Auto M. w/Smartcard A FLEX US model number DS510S;
d) REMStar Auto M. w/Smartcard, CNDA model number CA501S;
e) REMStar Auto M w/Smartcard Intl model number IN501S;
f) REMStar Auto M w/Smartcard US model number DS500S;
g) REMStar Auto w/C-FLEX CANADA model number CA1017454;
h) REMStar Auto w/C-FLEX Domestic Core Pkg model number 1017476.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1065-2008;
12) REMStar Heated Humidifier Pkg model number 1005792. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1066-2008;
13) Non-continuous ventilator accessories under the following brand names:
a) REMStar M US model number DS100;
b) REMStar M w/Humid US model number DS100H.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1067-2008;
14) Non-continuous ventilator accessories under the following brand names:
a) REMStar Plus M US model number DS200;
b) REMStar Plus M w/Humid AHP model number AHP200H;
c) REMStar Plus M w/Humid US model number DS200H;
d) REMStar Plus M w/Humid, w/Smartcard, AHP model number AH200HS;
e) REMStar Plus M w/Smartcard, US model number DS200S;
f) REMStar Plus w/C Flex Dom model number 1009586.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1068-2008;
15) Non-continuous ventilator accessories under the following brand names:
a) REMStar Pro2 Domestic model number 1020923;
b) REMStar Pro M, w/Humid w/Smartcard US model number DS400HS;
c) REMStar Pro M w/Smartcard US model number DS400S;
d) REMStar Pro/Plus Silencer Cap model number 1005962;
e) REMStar Pro/Plus/Auto/Lite Pollen model number 1005964;
f) REMStar Pro/Plus/Auto/Lite Pollen SNGL model number 1001389;
g) REMStar Pro/Plus/Auto/Lite Ultrafine model number 1005945;
h) REMStar Pro/Plus/Auto/Lite Ultrafine Qty 1 model number 1039607.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1069-2008;
16) Rotating Connector Packaged model number 302209. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1070-2008
17) Non-continuous ventilator accessories under the following brand names:
a) RP-L ComfortGel Cush and Flap model number 1031404;
b) RP-M ComfortGel Cush and Flap model number 1031403. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1071-2008;
18) RP M Series Pollen Filter Kit 1 pack model number 1035443, Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1072-2008;
19) Non-continuous ventilator accessories under the following brand names:
a) RP-P ComfortGel Cush and Flap model number 1031391 and b) RP-S
ComfortGel Cush and Flap model number 1031392. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1073-2008;
20) Power Supply under the following brand names:
a) RP, Power Supply Assembly model number H3600-015,
b) RP, Wiring Harness, Lamp Holder model number H3600-020. Filter, mask,
and/or accessories for sleep therapy and ventilation devices, Recall # Z-1074-2008;
21) RP-Assy, Cover, DC-5 pack model number F35933. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1075-2008;
22) Non-continuous ventilator accessories under the following brand names:
a) RP-BIPAP Flow Pick-Up Tube Kit model number 332185;
b) RP-BIPAP M Series Keypad model number 1038122; and
c) RP-BIPAP Pro 2 /Plus Tubing Kit model number 1020358.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1076-2008;
23) RP-Cable DC 6 w/Ring PLV RBL POR model number FC07270. Filter, mask,
and/or accessories for sleep therapy and ventilation devices, Recall # Z-1077-2008;
24) RP C-Flex Mini Din Plug model number 1011220. Filter, mask, and/or accessories
for sleep therapy and ventilation devices, Recall # Z-1078-2008;
25) Non-continuous ventilator accessories under the following brand names:
a) RP-ComfortGel Gel Cushion M model number 1009050;
b) RP-ComfortGel Gel Cushion P model number 1009048;
c) RP-ComfortGel Gel Cushion S model number 1009049;
d) RP-ComfortGel Silicone Flap L model number 1009109;
e) RP-ComfortGel Silicone Flap M model number 1009054; and
f) RP-ComfortGel Silicone Flap S model number 1009053.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1079-2008;
26) RP Diaphragm Exhalation model number FC06372. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1080-2008;
27) RP Duet LX/Pro Out Port w/Seal model number 622239. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1081-2008;
28) RP-Leaf, Check valve-5 pk model number F33440. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1082-2008;
29) RP-REM Auto w/C-FLEX/REM Pro Tubing Kit model number 1008492 and RP-
REM Power Cord N. AMER model number 362524. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1083-2008;
30) RP-REMStar Plus Keypad model number 1006852. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1084-2008;
31) Continuous ventilator accessories under the following brand names:
a) RP-Seal, Spring-5 pk model number F35465;
b) RP-Seal, Greece, Ballscrew model number F35036;
c) RP-Tub PVC 1/8 in x ¼ 50 ft model number 1008841;
d) RP-Vision Filter Cover model number 1003444;
e) RP-Vision RS-232 HRN ABV 106K model number 1004699; and
f) RP-Wrap, Cord model number F35195.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1085-2008;
32) APNEA monitor accessories under the following brand names:
a) SM 2 PS/PSL, Prof. Operators Manual, NL-NL model number 1025422;
b) SM 2/2 PS Europe Patient Cable, Metal model number 1030194; and
c) Smartmonitor 2 with modem, PCMCIA model number 4003.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1086-2008;
33) Breathing Frequency Monitor Stardust 2 Domestic model number 1025720.
Filter, mask, and/or accessories for sleep therapy and ventilation devices,
Recall # Z-1087-2008;
34) Non-continuous ventilators under the following brand names:
a) Sync S/T Lab, w/o modem US/CAN model number 1010771;
b) Sync S/T Lab, w/o modem US/CAN-RENT model number R1010771;
c) Synchrony S w/o modem US/CAN model number 1002816;
d) Tranquility Ultrafine Qty 1 model number 1039671; and
e) Tubing Coupler model number 300065. Filter, mask, and/or accessories for
sleep therapy and ventilation devices, Recall # Z-1088-2008;
35) Stardust Flexible Y Sensor Probe model number 612054. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1089-2008;
36) ECG Lead Set 60 in SOC to Snap model number 8049-1. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1090-2008;
37) Oximeter Patient Cable Masimo 8 ft model number H5870. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1091-2008;
38) Oximetry Ear Clip Sensor model number 948. Filter, mask, and/or accessories for
sleep therapy and ventilation devices, Recall # Z-1092-2008;
39) Lead Wire Pin/Socket 24 in 1 pr model number 9520. Filter, mask, and/or
accessories for sleep therapy and ventilation devices, Recall # Z-1093-2008
CODE
Lot Numbers 071010, 071011, and 071012
RECALLING FIRM/MANUFACTURER
Respironics, Inc., Murrysville, PA, by letter dated October 18, 2007. Firm initiated recall is ongoing.
REASON
Foreign material: Glass fragments may present in the plastic bag material used to ship components.
VOLUME OF PRODUCT IN COMMERCE
20,950 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
CELL-DYN Hemoglobin Reagent Syringe used on the CELL-DYN Sapphire Automated Hematology Analyzer. Each package is identified with product description "CDS HGB SRNG W/BU", Recall # Z-1165-2008
CODE
All Hemoglobin Reagent Syringes, List No. 08H49-02, with packaging dates between May 8, 2007 and November 29, 2007
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara, CA, by letter on January 11, 2008 and January 15, 2008. Firm initiated recall is ongoing.
REASON
Count may be out of specification--Hemoglobin background count may be out of specification (high) after installation of new CELL-DYN Sapphire Hemoglobin Reagent Syringes with packaging dates between May 8, 2007 and November 29, 2007.
VOLUME OF PRODUCT IN COMMERCE
2,742 syringes
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
a) MGA200 Premix (Type A Medicated Article), each pound contains 200 mg.
Melengestrol Acetate, packaged in a white, multi-layered paper bag containing
approximately 10 lbs. of product with the drug name handwritten on it,
Recall # V-037-2008;
b) Lincomix 20 (lincomycin) Type A Medicated Article 20 grams/lb, packaged in a
white, multi-layered paper bag containing approximately 5 lbs. with the drug name
handwritten on it, Recall # V-038-2008
CODE
No lot number
RECALLING FIRM/MANUFACTURER
Milbank Mills Inc., Chillicothe, MO, by letters dated January 30, 2008. Firm initiated recall is complete.
REASON
The product was repackaged with deficient labeling.
VOLUME OF PRODUCT IN COMMERCE
10 lbs. MGA200 and 5 lbs. Lincomix
DISTRIBUTION
MO
END OF ENFORCEMENT REPORT FOR APRIL 30, 2008
###
RSS Feed for FDA Enforcement Report [what is RSS?]