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 8, 2005
05-23

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS I

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PRODUCT
Assi Brand Dried Bellflower Root, net wt. 15 oz, packaged in plastic bags labeled in part***06034K***Product of China***. Recall # F-419-5.
CODE
Dried Bellflower Root product is identified by item code "06034K" printed on the package. The product is not coded by lot number.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rhee Brothers Incorporated, Columbia, MD, by Press Release on April 28, 2005 and letters on April 30, 2005.
Manufacturer: Zibo Juyuan Food Co., Ltd., Shandong, China. Firm initiated recall is ongoing.
REASON
Imported food product contains undeclared sulfites. Sensitized individuals may run risk of serious life-threatening allergic reactions if they consume product.
VOLUME OF PRODUCT IN COMMERCE
4,640 packages
DISTRIBUTION
Eastern US and Canada

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS II

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PRODUCT
Celery root, packed 12 in a generic produce box. Recall # F-345-5.
CODE
The product is not coded.
RECALLING FIRM/MANUFACTURER
Trapold Farms, Portland, OR, by telephone on March 7, 2005. Firm initiated recall is complete.
REASON
The product contains linuron pesticide residue.
VOLUME OF PRODUCT IN COMMERCE
638 cases, each containing 12.
DISTRIBUTION
OR, and WA.

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS - CLASS III

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PRODUCT
Archer Farms brand Espresso Mocha Cookies, 7 oz. in paper carton packages; 12 packages per case. Recall # F-420-5.
CODE
Lot No 08/05
RECALLING FIRM/MANUFACTURER
Too Good Gourmet Inc., San Lorenzo, CA, by telephone on March 22, 2005 and press release on March 29, 2005. Firm initiated recall is ongoing.
REASON
Packages of cookies labeled as "Espresso Mocha Cookies" actually contain "Chocolate Chunk Cookies".
VOLUME OF PRODUCT IN COMMERCE
192 Cases/12 units per case
DISTRIBUTION
Nationwide

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PRODUCT
Plates labeled: "Sommelier ***Cheese Plates ***Wine Art *** Set of 4 Porcelain Plates", packaged in decorative small wood crates. Product of China." UPC code: 67742 90669. Recall # F-423-5.
CODE
There are no lot numbers
RECALLING FIRM
Recalling Firm: MSC International Inc., Saint-Laurent, Canada, by letters on April 1, 2005.
Manufacturer: Free Yon Trading Co, Kowloon, China. Firm initiated recall is ongoing.
REASON
Plates contain elevated leachable levels of lead.
VOLUME OF PRODUCT IN COMMERCE
3,480 sets (4 plates each)
DISTRIBUTION
AZ, CA, FL, MA, NJ, NY, PA and Iceland

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
A) Nefazodone HCl Tablets, 50mg, bottles of 60, 100, and
unit dose cartons of 100, Rx only, ***** NDC 0172-4343-
49. Recall # D-239-5;
b) Nefazodone HCl Tablets, 100mg, bottles of 60, 100, and
500 and unit dose cartons of 100, Rx only, *****NDC
0172-4332-49. Recall # D-240-5;
c) Nefazodone HCl Tablets, 150mg, bottles of 60, 100, and
500 and unit dose cartons of 100, Rx only, ****
NDC 0172-4333-49. Recall # D-241-5;
d) Nefazodone HCl Tablets, 200mg, bottles of 60, 100, and
500 and unit dose cartons of 100, Rx only, ***** NDC
0172-4334-49. Recall # D-242-5;
e) Nefazodone HCl Tablets, 250mg, bottles of 60 and 100, Rx
only, ***** NDC 0172-4335-49. Recall # D-243-5.
CODE
a) Lot Number 122321, exp. 01/2006; 120257, exp. 12/2005;
120720, exp. 01/2006; 118544, exp. 06/2005; 118545, exp.
06/2005; 118557, exp. 06/2005; 118557A, exp. 06/2005;
b) Lot Number 120712, exp. 12/2005; 118550, exp. 07/2005;
120236, exp. 10/2005; 118540, exp. 06/2005; 118546, exp.
06/2005;
c) Lot Number 125021, exp. 03/2006; 120237A, exp. 09/2005;
122816, exp. 01/2006; 120238, exp. 09/2005; 118541, exp.
06/2005; 118547, exp. 06/2005; 118551, exp. 06/2005;
120237, exp. 09/2005; 118552, exp. 06/2005;
d) Lot Number 120252, exp. 12/2005; 120714, exp. 03/2006;
120253, exp, 12/2005; 120251, exp. 10/2005; 118542, exp.
06/2005; 118548, exp. 06/2005; 118553, exp. 07/2005;
118554, exp. 07/2005; 118556, exp. 07/2005; 120250, exp.
10/2005; 118555, exp. 07/2005;
e) Lot Number 120255A, exp. 10/2005; 120255, exp. 10/2005;
118543, exp. 05/2005; 118549, exp. 06/2005.
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami, FL, by letters on March 21, 2005.
Manufacturer: Ivax Pharmaceuticals Inc, Northvale, NJ. Firm initiated recall is ongoing.
REASON
Dissolution Failure
VOLUME OF PRODUCT IN COMMERCE
412,350 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: Devices - CLASS II

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PRODUCT
Arrow Continuous Nerve Block Needle, Latex-Free, Rx only, Sterile.
Recall # Z-0852-05.
CODE
Product #AB-17040-N, AB-17080-N, AB-17110-N, AB-17140-N, AB-18040-N, AB-18080-N,
AB-18110-N, AB-18140-N, AB-19604-K, AB-19604-S, AB-19608-K, AB-19608-S, AB-20604-K,
AB-20604-S, AB-20608-K, AB-20608-S
RECALLING FIRM/MANUFACTURER
Arrow International Inc., Reading, PA, by letter on/about February 17, 2005. Firm initiated recall is ongoing.
REASON
Possible difficulty in passing the catheter through the needle due to a reduced ID of the needle caused by over crimping of the needle during the manufacturing process.
VOLUME OF PRODUCT IN COMMERCE
8,058 units
DISTRIBUTION
Nationwide, Africa, France, Holland, and Rotterdam

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PRODUCT
a) Baxter PosiFlow Access Device for IV Access; PRODUCT
code 2N9050; a single use, sterile device with PosiFlow
Positive Displacement Feature and Male Luer Lock
Adapter, 0.06 mL. Recall # Z-0853-05;
b) Baxter Extension Sets with PosiFlow Access Device for IV
Access; Product codes 2N9051, 2N9052, 2N9053, 2N9054,
2N9055, 2N9057; a single use, sterile fluid pathway
devices with PosiFlow Positive Displacement Feature.
Recall # Z-0854-05.
CODE
All lots.
RECALLING FIRM
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated March 3, 2005.
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, Aibonito, PR. Firm initiated recall is ongoing.
REASON
Inadequate directions for use resulting in fluid leaks, valves sticking in the open position, and flow output restriction.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
Nationwide

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PRODUCT
Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature management unit. Not sterile. Do not use I f primary packaging has been previously opened or is damaged. Recall # Z-0855-05.
CODE
Lot numbers ranging from 9631 up to and including 9657
RECALLING FIRM/MANUFACTURER
Arizant Inc., Eden Prairie, MN, by letters beginning March 11, 2005. Firm initiated recall is ongoing.
REASON
Air channel seals on a limited number of Bair Hugger Model 555 Pediatric underbody blankets could separate when inflated with air from Bair Hugger warming unit. This separation would create a bulging area in the blanket's air channels, which could have a potential to shift the patient's position on the blanket.
VOLUME OF PRODUCT IN COMMERCE
88,320 blankets
DISTRIBUTION
Nationwide

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PRODUCT
Discovery Channel brand 8-Way Massager with Heat; therapeutic massager; Model Number 4196-1. The model number and date code are molded into the side of the handle of the massager near the on/off switch. Recall # Z-0856-05.
CODE
Date code 054
RECALLING FIRM
Recalling Firm: Wahl Clipper Corp, Sterling, IL, by a Stop Sales notice on/or about December 10, 2004.
Manufacturer: Wahl Clipper Ningbo Ltd, Zhejiang, China. Firm initiated recall is ongoing.
REASON
The housing of the massager's heating applicator attachment may crack during use. If the plastic housing cracks and breaks it could expose the user to live electrical connections and pose a shock hazard.
VOLUME OF PRODUCT IN COMMERCE
4,200 plastic heat applicators
DISTRIBUTION
Nationwide and PR

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PRODUCT
a) Aortic Valve & Conduit, Donor #77647, Model #AV00.
Recall # Z-0859-05;
b) Pulmonary Valve & Conduit. Donor #77647, Model #PV00.
Recall # Z-0860-05.
CODE
a) Serial #8461379;
b) Serial #8471383
RECALLING FIRM/MANUFACTURER
Cryolife, Inc, Kennesaw, GA, by telephone on May 17, 2005. Firm initiated recall is complete.
REASON
Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
VOLUME OF PRODUCT IN COMMERCE
2 tissues
DISTRIBUTION
IL, MT

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PRODUCT
Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10. Recall # Z-0864-05.
CODE
Chisel lot number 60048084
RECALLING FIRM
Zimmer Inc., Warsaw, IN, by email on February 9, 2005. Firm initiated recall is ongoing.
REASON
The engraved calibration lines are incorrectly specified, which will result in the user obtaining a reading that the chiseling removed material to a depth 10mm deeper than what was actually removed, thus guiding the user to select a blade plate that is longer than will fit.
VOLUME OF PRODUCT IN COMMERCE
37
DISTRIBUTION
Nationwide and Canada

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PRODUCT
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01). Recall # Z-0865-05.
CODE
Serial numbers for domestic units: A21000015, A21000016, A21000018, A23000040, A23000042, A23000047, A24000051, A24000052, A24000054, A24000055, A24000056, A24000057, A24000060, A24000061, A24000067, A24000073, A24000076, A24000077, A24000084, A24000087, A24000096, A24000101, A24000104, A25000106, A25000108, A25000110, A25000115, A25000116, A25000118, A25000126, A25000130, A25000131, A25000133, A25000136, A25000137, A25000143, A25000144, A25000145, A25000146, A25000147, A25000148, A26000153, A26000154, A26000157, A26000159, A26000160, A26000161, A26000164, A26000165, A26000167, A26000170, A26000171, A26000173, A26000176, A26000178, A26000179, A26000180, A27000181, A27000184, A27000186, A27000188, A27000189, A27000192, A27000194, A27000197, A27000198, A27000200, A27000202, A27000203, A27000204, A27000210, A27000211, A27000212, A28000220, A28000226, A28000229, A28000230, A28000231, A28000235, A28000238, A28000241, A28000243, A28000247, A28000250, A28000253, A28000255, A28000257, A28000260, A28000262, A28000265, A28000267, A28000270, A28000273, A28000275, A28000276, A28000277, A28000280, A28000281, A29000289, A29000290, A29000292, A29000300, A29000310, A29000318, A29000319, A29000323, A29000325, A2A000327, A2A000330, A2A000335, A2A000337, A2A000338, A2A000340, A2A000344, A2A000345, A2A000348, A2A000349, A2A000350, A2A000353, A2A000354, A2B000358, A2B000365, A2B000372, A2B000374, A2B000381, A2B000385, A2B000395, A2B000399, A2B000408, A2B000411, A2B000420, A2C000437, A2C000438, A2C000439, A2C000440, A2C000441, A2C000443, A2C000444, A2C000445, A2C000446, A2C000447, A2C000448, A2C000449, A2C000450, A2C000451, A2C000452, A2C000455, A2C000456, A2C000457, A2C000458, A2C000459, A2C000460, A2C000462, A2C000463, A2C000465, A31000466, A31000467, A31000468, A31000470, A31000474, A31000475, A31000477, A31000478, A31000479, A31000480, A31000481, A31000482, A31000488, A31000489, A31000491, A31000492, A31000493, A32000483, A32000490, A32000495, A32000498, A32000499, A32000501, A32000502, A32000505, A32000507, A32000509, A32000513, A32000515, A32000516, A32000517, A33000523, A33000528, A33000534, A33000536, A33000540, A33000546, A33000549, A33000550, A34000556, A34000557, A34000559, A34000560, A34000563, A34000565, A34000567, A34000568, A34000577, A34000578, A34000582, A34000587, A34000588, A34000589, A34000595, A34000596, A34000597, A34000599, A34000603, A34000606, A34000607, A34000611, A34000612, A34000614, A34000615, A34000616, A34000621, A34000623, A34000627, A34000628, A34000629, A35000630, A35000636, A35000637, A35000641, A35000642, A35000643, A35000644, A35000645, A35000649, A35000650, A35000652, A35000654, A35000659, A35000663, A35000664, A35000665, A35000669, A36000670, A36000674, A36000677, A36000678, A36000687, A36000692, A36000694, A36000702, A36000705, A36000706, A36000707, A36000716, A36000717, A37000720, A37000721, A37000723, A37000732, A37000735, A37000736, A37000738, A37000743, A38000753, A38000756, A38000760, A39000767, A39000769, A39000776, A39000778, A39000780, A39000783, A3B000790, A3B000794, A3B000796, A3B000799, A3B000802, A3B000804, A3B000806, A3C000812, A3C000813, A3C000824, A3C000825, A3C000826, A3C000846, A3C000850, A3C000853, A3C000854, A41000858, A41000861, A41000865, A41000869, A41000872, A41000873, A42000885, A42000887, A42000889, A42000891, A42000892, A42000893, A42000894, A42000895, A42000896, A42000897, A42000898, A42000899, A42000901, A42000903, A42000906, A42000907, A42000912, A42000913, A42000916, A42000921, A42000922, A42000925, A42000928, A42000931, A42000932, A42000934, A42000941, A42000945, A42000947, A42000952, A42000959, A43000980, A43000982, A43000995, A43001003, A43001005, A43001006, A44001017, A44001018, A44001019, A44001022, A44001026, A44001027, A44001028, A44001032, A44001038, A44001045, A45001050, A45001051, A45001053, A45001058, A45001061, A45001066, A45001073, A45001077, A45001084, A45001089, A45001100, A45001104, A45001106, A45001112, A45001117, A46001125, A46001133, A46001142, A46001143, A46001144, A46001157, A46001160, A46001177, A46001184, A46001193, A46001198, A47001201, A47001208, A47001219, A47001225, A47001230, A47001235, A47001237, A47001245, A47001247, A47001250, A47001253, A47001259, A48001271, A48001282, A48001283, A48001284, A48001288, A48001290, A48001294, A48001295, A49001312, A49001313, A49001327, A49001341, A4A001347, A4A001353, A4A001357, A51001373, A51001383, A51001389
RECALLING FIRM/MANUFACTURER
Philips Ultrasound, Inc., Bothell, WA, by letter on May 6, 2005. Firm initiated recall is ongoing.
REASON
The acoustic display of Mechanical Index and Thermal Index is inaccurate - two transducers may exceed limits for acoustic intensity and MI.
VOLUME OF PRODUCT IN COMMERCE
1,225 units
DISTRIBUTION
Nationwide and Internationally.

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PRODUCT
VITROS VALP Reagent, REF 680 1710. Each box contains 6 packs. Each pack contains liquid reagent for 50 tests. Recall # Z-0866-05.
CODE
01-5871, Exp. 31Jan06
RECALLING FIRM
Ortho-Clinical Diagnostics, Rochester, NY, by letters dated April 18, 2005. Firm initiated recall is complete.
REASON
Negatively biased results may be observed when the reagent is stored on the VITROS 5,1FS Chemistry System for less than seven days.
VOLUME OF PRODUCT IN COMMERCE
139 boxes
DISTRIBUTION
Nationwide, England, France and Spain

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PRODUCT
a) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 7.0mm Product Number: 535070. Recall # Z-0867-05;
b) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 8.0mm Product Number: 535080. Recall # Z-0868-05;
c) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 9.0mm Product Number: 535090. Recall # Z-0869-05;
d) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 7.0mm Product Number: 538070E. Recall # Z-0870-05;
e) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 8.0mm Product Number: 538080E. Recall # Z-0871-05;
f) Portex Per-Fit Percutaneous Dilational Tracheostomy Kit,
ID 9.0mm Product Number: 538090E. Recall # Z-0872-05.
CODE
a) Lot Numbers: K518075, K520177, K548751, K573622,
K614995;
b) Lot Numbers: K515073, K515074, K515075, K518076,
K518077, K520176, K523556, K527903, K548745, K559483,
K614996, K630177;
c) Lot Numbers: K515076, K518078, K558496, K586109,
K614402, K629274;
d) Lot Number: K510891;
e) Lot Numbers: K510892, K565595;
f) Lot Number: K510893
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by letter on/about May 16, 2005. Firm initiated recall is ongoing.
REASON
Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
VOLUME OF PRODUCT IN COMMERCE
2,572 cases
DISTRIBUTION
Nationwide, Canada, Mexico and East Timor

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Mick TP Prostate Seeding Needles, 18 Gauge, Catalog/Model Number MTP-1820-C. --- Brand Name: Mick TP Disposable Needle 18 Gauge. Common/Usual Name: TP Needle 18 Gauge. Classification Name: System, Applicator, Radionuclide, Manual. The needle is an accessory to the Mick 200-TPV Applicator and Kit. This one time use needle is used for brachytherapy. The product is sold in cartons with each carton containing a total of 25 needles. Each carton contains 4 packages of 5 needles, and 5 packages containing one needle each. Recall # Z-0857-05.
CODE
Lots: M121504-07 (Exp. 12/15/2009), M012605-01 (Exp. 1/26/2010), M012805-01 (Exp. 1/28/2010).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mick Radio Nuclear Instruments, Inc., Mount Vernon, NY, by letters on March 30, 2005, and telephone on April 22, 2005.
Manufacturer: Manan Medical Products, Inc., Wheeling, IL. Firm initiated recall is ongoing.
REASON
Some of the Mick TP Prostate Seeding Needles do not fit properly into the Mick 200-TPV Applicator.
VOLUME OF PRODUCT IN COMMERCE
327 cartons.
DISTRIBUTION
Nationwide, Sweden and The Netherlands.

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PRODUCT
Portex Hypodermic Needle-Pro Syringe & Needle 3mL/LL 25G x 1", Catalog Number: 4238. Recall # Z-0858-05.
CODE
Lot Number: K621494.
RECALLING FIRM
Smiths Medical ASD, Inc., Keene, NH, by telephone on May 5, 2005, May 12, 2005 and by letter on May 17, 2005. Firm initiated recall is ongoing.
REASON
Mislabeled: Product may contain an incorrect needle size. Product labeled as a 25G x 1" may contain a 25G x 5/8".
VOLUME OF PRODUCT IN COMMERCE
159 cases (400 per case) = 63,600 each.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR June 8, 2005

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