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U.S. Department of Health and Human Services

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Enforcement Report for August 30, 2006

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.

 

August 30, 2006
06-35

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS I

______________________________
PRODUCT
Harry and David Wild N Spicy Hot Chili Pepper Tortilla Chips in 14 oz. bag, Recall # F-288-6
CODE
Expiration dates to include May 1, 2006 through November 11, 2006.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harry & David, Medford, OR, by e-mail and telephone on July 13, 2006 and by press release on July 14, 2006
Manufacturer: Bien Padre Foods, Inc., Eureka, CA. Firm initiated recall is complete.
REASON
Seasoning mix used in manufacturing the product contained whey, which was not declared on the label of the chips.
VOLUME OF PRODUCT IN COMMERCE
47,300/14 oz. bags
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Tina's Brand 3 Pak Mini Muffin Banana 3.5 oz, Items Number: 021133 (12 Mini Muffin Assorted 3 pak), Recall # F-290-6
CODE
All manufacturers' codes less than 0617501. Code breakdown is: 06 is year; 175 is Julian date of June 24 when labels were corrected; and 01 is batch number.
RECALLING FIRM/MANUFACTURER
Tina's, Inc., Anaheim, CA, by letter and press release as of June 28, 2006. Firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
18,281
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Duncan Hines Chocolate Lover's Double Fudge Brownies, Double Fudge in 17.6 oz. retail cartons, UPC Code 6-44209-33247-2, Recall # F-291-6
CODE
Retail cartons have "Best if used by Jan 09 07." Shipping cases are labeled with lot # GC09017E61.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pinnacle Food Corp., Mountain Lakes, NJ, by press release and e-mail on March 17, 2006.
Manufacturer: Gilster-Mary Lee Corp., Centralia, IL. Firm initiated recall is ongoing.
REASON
The product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
Approximately 350 cartons
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: FOODS AND COSMETICS -- CLASS II

______________________________
PRODUCT
Tina's Brand Monster Banana Muffin 6 oz, Items Numbers: 025041 (12 Banana Muffin 6 oz) & 025641 (6 Banana Muffin 6 oz), Recall # F-289-6
CODE
All manufacturers' codes less than 0617501. Code breakdown is: 06 is year; 175 is Julian date of June 24 when labels were corrected; and 01 is batch number.
RECALLING FIRM/MANUFACTURER
Tina's, Inc., Anaheim, CA, by letter and press release as of June 28, 2006. Firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts, which are obviously visible on the top.
VOLUME OF PRODUCT IN COMMERCE
18,281
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Exfoliant 30% under Coats Aloe brand name in 2 oz. and 8 oz. sizes (item # FX30002 and FX30008, respectively) and under Aesthetics Medical, Inc. brand name in the 2 oz. size (item # PL024104); products packaged in white HDPE bottles with orifice reducer and white screw-on lids, Recall # F-292-6
CODE
Lot: 01206B
RECALLING FIRM/MANUFACTURER
Coats Aloe International, Inc., Garland, TX, by letter on July 26, 2006. Firm initiated recall is ongoing.
REASON
Topical cosmetic exfoliant contains low level of pH, which may cause burns to skin.
VOLUME OF PRODUCT IN COMMERCE
155 total bottles
DISTRIBUTION
CA, FL, MD, NJ, NY, PA and TX
 

 RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS I

______________________________
PRODUCT
Azathioprine Tablets, USP, 50 mg, 100 tablet bottles, Rx only, NDC 0054-4084-25, Recall # D-337-6.
CODE
Lot #558470A, exp. date Mar 2009.
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Roxane Inc, ColumbusOH, by letter on July 10 and July 11, 2006 and by press release on July 13, 2006. Firm initiated recall is ongoing.
REASON
Label Mixup; product labeled to contain Azathioprine, 50 mg Tablets may actually contain Methotrexate, 2.5 mg Tablets.
VOLUME OF PRODUCT IN COMMERCE
8,742/100 tablet bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Triaminic Vapor Patch Cough, Menthol Cough Suppressant,
(menthol), 2.6%, Mentholated Cherry Scent, 6 Chest Patches
per box and professional samples, Recall # D-342-6;
b) Triaminic Vapor Patch Cough, Menthol Cough Suppressant,
(menthol) 2.6%, Menthol Scent, 6 Chest Patches per box and
professional samples, Recall # D-343-6.
CODE
All products in commerce.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Novartis Consumer Health Inc., ParsippanyNJ, by press release on June 19, 2006 and by letters on June 19, 2006 and July 11, 2006.
Manufacturer: Novartis Consumer Health Inc, LincolnNB. Firm initiated recall is ongoing.
REASON
Misbranded; Use of the product on young children can pose health risks due to potential accidental ingestion.
VOLUME OF PRODUCT IN COMMERCE
Mentholated Cherry - 4,069,195/6-ct. boxes and 113,088/1-ct. professional samples; menthol - 857,026/6-ct. boxes
DISTRIBUTION
Nationwide, Canada and Panama

______________________________
PRODUCT
a) Extra Strength GENAPAP Tablets, acetaminophen (APAP),
500 mg EACH, 100 count bottles, ASPIRIN-FREE, PAIN
RELIEVER/FEVER REDUCER, NDC 0182-1457-01,
Recall # D-344-6;
b) Extra Strength GENAPAP Caplets, acetaminophen (APAP),
500 mg EACH, 100 count bottles, ASPIRIN-free, PAIN
RELIEVER/FEVER REDUCER, NDC 0182-2152-01,
Recall # D-345-6;
c) Extra Strength GENEBS Tablets, acetaminophen, 500 mg
EACH, 100 and 1000 count bottles, PAIN RELIEVER/FEVER
REDUCER, NDC 0182-1832-01, Recall # D-346-6;
d) Extra Strength GENEBS Caplets, acetaminophen, 500 mg
EACH, 100 and 1000 count bottles, PAIN RELIEVER/FEVER
REDUCER, Recall # D-347-6
CODE
a) Lot Numbers: 5L020B;
b) Lot Numbers: 5H018D;
c) Lot Numbers: 5J006A, 5F001, 5H007, 5H007B, 5L014, 5L018, 5L019;
d) 5B003, 5F002, 5F004A, 5H003A, 5H005, 5H015, 5H016,
5H018B, 5M024, 5M030A, 6A014, 6B022B, 5B016, 5F004,
5F010, 5F010C, 5H003, 5H018A, 5L009B, 5M008A, 5M030
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, MiamiFL, by press release on 5/2/06 and by letter on 5/3/06.
Firm initiated recall is ongoing.
REASON
Misbranded; the labeling on the product incorrectly states, "do not take more than 12 caplets in 24 hours". The correct statement should state, "do not take more that 8 caplets in 24 hours"
VOLUME OF PRODUCT IN COMMERCE
211,955
DISTRIBUTION
Nationwide and PR
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Bravelle®, urofollitropin for injection, purified, 75 IU, Rx only, NDC 55566-8505-6. Box contains 5 product vials + 5 vials diluent + 5 vial adapters, Recall # D-328-6
CODE
Lot: FMA038B-1, Exp. 5/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ferring Pharmaceuticals, Inc., Suffern, NY, by telephone on June 5, 2006 and by fax on June 8, and June 9, 2006.
Manufacturer: Cardinal Health, Albuquerque, NM. Firm initiated recall is ongoing.
REASON
Stability sample tested at 3 months exceeds specification for rate of oxidation of alpha subunits.
VOLUME OF PRODUCT IN COMMERCE
648 boxes (5 vials per box)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Levoxyl ® (levoxyroxine sodium tablets, USP), 75 mcg 100 count bottles,
Rx Only, NDA: 201-301 NDC: 52604-5075-1, Recall # D-332-6;
b) Levoxyl ® (levoxyroxine sodium tablets, USP), 112mcg, 100 and
1000-count bottles, Rx Only, NDA: 201-301 NDC: 52604-5112-1
and 52604-5112-2, Recall # D-333-6;
c) Levoxyl ® (levoxyroxine sodium tablets, USP), 125mcg, 100 and
1000-count bottles, Rx Only, NDA: 201-301 NDC: 52604-5125-2
and 52604-5112-2, Recall # D-334-6
CODE
a) Lot: 7240, SAP batch 21272;
b) Lots: 9227 and 9248, SAPs 21274 and 21324;
c) Lots: 9222, 9228 and 9212. SAPs 21268, 21271 and 21267
RECALLING FIRM/MANUFACTURER
Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN, by letter on August 1, 2006.
Manufacturer: King Pharmaceuticals, Inc. (St. Petersburg Facility), Saint Petersburg, FL. Firm initiated recall is ongoing.
REASON
Potential sub-potency at 15-month stability interval.
VOLUME OF PRODUCT IN COMMERCE
108,351
DISTRIBUTION
Nationwide and PR

______________________________
PRODUCT
Cocaine Hydrochloride Topical Solution 4 % packed in 4mL glass bottles, Recall # D-335-6
CODE
Lot: 656429A, Expiration Date: Apr 07, and Lot: 656795B, Expiration Date: May 07.
RECALLING FIRM/MANUFACTURER
Boehringer Ingelheim Corp., Columbus, OH, by letter on July 31, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: The folding carton for the Cocaine Hydrochloride 4% topical solution lists the incorrect milligram strength for the product.
VOLUME OF PRODUCT IN COMMERCE
44,452 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Hydroxyzine Pamoate 25mg Capsules, USP, Rx only, 500 capsules, NDC 0172-2911-70, Recall # D-338-6
CODE
Lot # 132379B Exp 10/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, MiamiFL, by letter on July 11, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., CidraPR. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: For products and/or lots, unidentified extraneous peaks were noted at chromatographic analysis. Chromatographic analysis of extraneous peaks was determined to be insufficient.
VOLUME OF PRODUCT IN COMMERCE
4,889 bottles of 500
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Nadolol 80mg Tablets USP, 100 Tablets, Rx only, Manufactured by: IVAX Pharmaceuticals, Inc., Miami, FL 33137, NDC 0172-4237-60, Recall # D-339-6
CODE
Lot # 141316A Exp 09/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, MiamiFL., by letter on July 11, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., CidraPR. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: For products and/or lots, unidentified extraneous peaks were noted at chromatographic analysis. Chromatographic analysis of extraneous peaks was determined to be insufficient.
VOLUME OF PRODUCT IN COMMERCE
3,487 bottles of 100 tablets
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Indomethacin 50mg Capsules USP, 500 capsules, Recall # D-341-6.
CODE
Lot # 139580A Exp 07/2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, MiamiFL., by letter on July 11, 2006.
Manufacturer: Ivax Pharmaceuticals, Inc., CidraPR. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: For products and/or lots, unidentified extraneous peaks were noted at chromatographic analysis. Chromatographic analysis of extraneous peaks was determined to be insufficient.
VOLUME OF PRODUCT IN COMMERCE
7,589 bottles of 500 count
DISTRIBUTION
Nationwide
 

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
CIS-Sulfur Colloid (Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection Diagnostic for Intravenous and Oral Use, Each 10 mL multidose reaction vial contains in lyophilized form 2.0 mg sodium thiosulfate anhydrous, 2.3 mg edtate disodium and 18.1 mg gelatin, Rx, Packaged under the CIS-US and private TSC Label, Recall # D-340-6.
CODE
Lots: 6433 through 6450 (expanded to lots 6451B and 6451C for replacement after Sept. 21, 2006).
RECALLING FIRM/MANUFACTURER
CIS-US, Inc., Bedford, MA, by letter dated July 27, 2006. Firm initiated recall is ongoing.
REASON
Stability of product is not assured to expiration.
VOLUME OF PRODUCT IN COMMERCE
128,425 vials
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II
 

______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced, Recall # B-1637-6;
b) Platelets, Recall # B-1638-6;
c) Recovered Plasma, Recall # B-1639-6
CODE
a), b), and c) Unit: 2472062
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on January 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt - Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX and Austria

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-1760-6;
b) Fresh Frozen Plasma, Recall # B-1761-6;
c) Red Blood Cells, Leukocytes Reduced, Irradiated,
Recall # B-1762-6;
d) Cryoprecipitated AHF, Recall # B-1763-6
CODE
a) Units: 4718752, 4718754, 4718759, 4718763, 4718816, 4718823,
4718824, 4718827, 4718865, 4718883, 4718888, 4718873, 4723226,
4724259, 4723232, 4723236, 4723241, 4723244, 4723247, 4721780,
4721777, 4721772, 4725377, 4725364, 4725354, 4725350, 4725343,
4725421, 4725423, 4725427, 4725415, 4725757, 4725500, 4725755,
4725752, 4725499, 4725495, 4721858, 4725777, 4725778, 4725796,
4725803, 4725805, 4725784, 4723862, 4723848, 4723850, 4723852,
4723856, 4723858, 4725855, 4725837, 4725839, 4725844, 4725846,
4725854, 4723943, 4723945, 4723947, 4723950, 4723952, 4723953,
4723955, 4723958, 4723960, 4723962, 4723964, 4723966, 4723989,
4725988, 4725990, 4725992, 4725996, 4725997, 4726000, 4725071,
4725073, 4725074, 4725078, 4692489, 4692491, 4692495, 4692496,
4692497, 4692499, 4709502, 4709503, 4709506, 4709508, 4709509,
4709512, 4709516, 4721994, 4721998, 4721999, 4722000, 4726007,
4726008, 4726012, 4726014, 4722989, 4722992, 4722993, 4722995,
4722997, 4722999, 4724001, 4724006, 4724010, 4724015, 4724016,
4724017, 4724021, 4724024, 4724031, 4724032, 4724034, 4724036,
4726388, 4726389, 4726392, 4726394, 4726020, 4726022, 4726055,
4726742, 4726757, 4728289, 4727382, 4727385, 4727394, 4727397,
4727391, 4727389, 4727378, 4727399, 4727404, 4727368, 4727370,
4727373, 4727365, 4728272, 4728275, 4728278, 4728279, 4728281,
4728288, 4728290, 4728293, 4728294, 4728295, 4728297, 4728299,
4728301, 4728304, 4724233, 4724238, 4724241, 4724245, 4724246,
4724249, 4730002, 4730003, 4730005, 4730008, 4730010, 4730013,
4730014, 4726166, 4728369, 4728371, 4728372, 4728374, 4728376,
4728377, 4728380, 4730298, 4730299, 4730302, 4730286, 4730289,
4730294, 4728053, 4728055, 4728056, 4728057, 4728060, 4728062,
4728064, 4728048, 4728051, 4730370, 4730372, 4730374, 4730378,
4730384, 4730388, 4730390, 4730397, 4730398, 4730399, 4728458,
4728460, 4728462, 4728465, 4728466, 4728469, 4728472, 4728483,
4728143, 4728147, 4728148, 4728150, 4728152, 4728153, 4728156,
4728159, 4728160, 4728163, 4728166, 4728168, 4728169, 4728172,
4730530, 4730535, 4730538, 4730539, 4730870, 4730871, 4730875,
4728207, 4728209, 4728212, 4728215, 4728220, 4728223, 4728225,
4709646, 4709649, 4709659, 4709662, 4709664, 4709666, 4709670,
6721280, 4729688, 6720016, 6720018, 6720019, 6720022, 6720024,
6720027, 6720028, 4729957, 4729960, 4729963, 4729964, 4729967,
4729970, 6720818, 6720827, 4730689, 4730696, 4730702, 4730703,
4730708, 4730710, 4730711, 4730712, 4730718, 4730722, 4730723,
4730724, 4730736, 4730739, 6722789, 6722791, 6722793, 6722795,
6722797, 6722800, 6722804, 6722808, 6722818, 6722813, 6722821,
6722824, 6722825, 6720912, 6720914, 6720916, 6720918, 6720922,
6720925, 6720927, 6720929, 6722859, 6722862, 6722865, 6722867,
6722869, 6722880, 6722881, 6722893, 6722884, 6722919, 6722920,
6720189, 6720994, 6720995, 6720996, 6720997, 6720998, 6722250,
6722251, 6722252, 6722254, 6722256, 6722258, 6722259, 6722261,
6722264, 6722266, 6722269, 6722270, 6722272, 6722275, 6722278,
6722281, 6722284, 6722286, 6722289, 6722292, 6722297, 6721069,
6721071, 6721085, 6721091, 6721093, 6721099, 6721132, 6723355,
6723351, 6723348, 6723344, 6723341, 6723337, 6723310, 6723314,
6723318, 6723321, 6723325, 6723329, 6723332, 6721806, 6721808,
6721810, 6721812, 6721816, 6721819, 6721821, 6723987, 6723991,
6723993, 6720502, 6720500, 6723996, 6722424, 6722427, 6722429,
6722430, 6722438, 6722433, 6722436, 6722439, 6722441, 6722443,
6722444, 6722448, 6722452, 6722458, 6722460, 6722462, 6723424,
6720563, 6720564, 6723427, 6723429, 6723432, 6723434, 6723437,
6723440, 6723447, 6723450, 6720607, 6720606, 6720609, 6720612,
6725008, 6725014, 6725022, 6725025, 6725029, 6720654, 6720665,
6720680, 6720725, 6720733, 6720734, 6720735, 6720739, 4709713,
6725379, 6721886, 6721888, 6721889, 6721891, 6725405, 6725406,
6725408, 6725412, 6725415, 6725417, 6726752, 6726762, 6725430,
6725433, 6725434, 6725436, 6725437, 6725439, 6725442, 6725445,
6725446, 6725448, 6725450, 6725452, 6725456, 6725459, 6725460,
6725461, 6725463, 6725464, 6725467, 6721934, 6721936, 6721937,
6721940, 6721941, 6721950, 6721952, 6722616, 6722618, 6722625,
6722626, 6722628, 6722633, 6722635, 6725495, 6725498, 6726250,
6726255, 6726256, 6726260, 6726264, 6726266, 6726267, 6726268,
6726270, 6721993, 6721996, 6726278, 6726280, 6726282, 6726283,
6726285, 6726286, 6726289, 6726985, 6726986, 6726989, 6727517,
6727520, 6727522, 6726292, 6727532, 6727533, 6723506, 6723509,
6723511, 6723515, 6723518, 6723519, 6723521, 6723524, 6723527,
6723566, 6723567, 6723569, 6723570, 6727663, 6727666, 6727672,
6727676, 6727678, 6727680, 6727683, 6727686, 6727689, 6727697,
6722709, 4709748, 4714504, 6722711, 6722714, 6722717, 6722718,
6722721, 6722722, 6723573, 6723575, 6723581, 6723587, 6723588,
6723589, 6723593, 6723598, 6723602, 6723604, 6723607, 6723609,
6723611, 6723616, 6723579, 6723584, 6723590, 6723586, 6723591,
6723594, 6723596, 6723597, 6723599, 6723603, 6723605, 6723612,
6723614, 6724516, 6724528, 6724530, 6724533, 6724535, 6724536,
6724539, 6724543, 6724546, 6728078, 6728079, 6728082, 6728085,
6728087, 6728088, 6728091, 6726529, 6726531, 6726533, 6726535,
6726537, 6726539, 6726546, 6726547, 6726549, 6726550, 6726552,
6726553, 6726556, 6723745, 6723747, 6723749, 6725501, 6725503,
6725505, 6725506, 6725508, 6725511, 6725513, 6725517, 6725522,
6726596, 6726598, 6726608, 6726610, 6726620, 6726624, 6726636,
6727232, 6727235, 6727238, 6727241, 6725550, 6725558;
b) Units: 4718759, 4718763, 4718816, 4718827, 4718865,
4718883, 4718888, 4718873, 4723216, 4723241, 4723244,
4723247, 4725421, 4725427, 4725415, 4725500, 4725499,
4725796, 4725805, 4723862, 4723858, 4725855, 4725846,
4725854, 4723955, 4723958, 4723960, 4723962, 4723964,
4723966, 4723989, 4725992, 4725996, 4725997, 4725073,
4725074, 4725078, 4709503, 4709506, 4709508, 4709509,
4709512, 4709516, 4726007, 4726008, 4726012, 4726014,
4724016, 4724034, 4726388, 4726389, 4726392, 4726394,
4726055, 4726742, 4726757, 4728288, 4728290, 4728293,
4728294, 4728295, 4728297, 4728299, 4728301, 4728304,
4724233, 4724238, 4730010, 4730013, 4730014, 4726166,
4728377, 4728380, 4730298, 4730299, 4730302, 4728055,
4728057, 4728060, 4728064, 4728051, 4728458, 4728460,
4728462, 4728469, 4728472, 4728483, 4728212, 4728220,
4728223, 4728225, 4709659, 4709666, 4709670, 4729688,
6720016, 6720019, 6720022, 6720024, 6720027, 6722813,
6722827, 6722270, 6721085, 6721091, 6721093, 6723351,
6723348, 6723341, 6723337, 6723332, 6721812, 6721816,
6721821, 6723993, 6720500, 6723996, 6722458, 6722462,
6723424, 6720563, 6723447, 6720607, 6720609, 6720612,
6725014, 6720665, 6720680, 6720733, 6720734, 6720735,
6720739, 4709713, 6721886, 6721888, 6721889, 6721891,
6725406, 6725408, 6725417, 6725464, 6725467, 6721946,
6721950, 6722633, 6722635, 6721993, 6726280, 6726282,
6726285, 6726286, 6727522, 6727532, 6727533, 6723506,
6723511, 6723515, 6723518, 6723519, 6723521, 6723566,
6723569, 6723587, 6723589, 6723593, 6723602, 6723604,
6723607, 6723616, 6723590, 6723586, 6723591, 6723594,
6723596, 6723597, 6723612, 6723614, 6724516, 6724533,
6724535, 6724539, 6724546, 6728078, 6728085, 6728087,
6728088, 6728091, 6726556, 6723745, 6723747, 6723749,
6725503, 6725505, 6725506, 6725508, 6725511, 6725513,
6725522, 6726624, 6726636, 6725558;
c) Units: 4723216, 4728269, 6722827, 6725028, 6720721,
6721946, 6726606, 6726615;
d) Units: 6722821, 6722824, 6722825, 6720189, 6722266,
6722278, 6723991, 6722460
RECALLING FIRM/MANUFACTURER
W. E. and Lela I. Stewart Blood Center, Inc., Tyler, TX, by letters dated August 11, 2004 and August 23, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
817 units
DISTRIBUTION
PA and TX
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III

______________________________
PRODUCT
Source Plasma, Recall # B-1340-6
CODE
Units: ST0869712, ST0870176, ST0870634 and ST0870918
RECALLING FIRM/MANUFACTURER
Stillwater Plasma Center LLC, Stillwater, OK, by letter, fax or telephone on June 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
UK

______________________________
PRODUCT
a) Cryoprecipitated AHF, Recall # B-1628-6;
b) Fresh Frozen Plasma, Recall # B-1629-6;
c) Fresh Frozen Plasma Pheresis, Recall # B-1630-6
CODE
a) Units: 2131556, 2131550, 2136773, 2131547, 2131557,
2138113, 2138121, 2138094, 2131559, 2131596, 2138032,
2131573, 2131567, 2136768, 2136772, 2136766, 2131572,
2136769, 2131563, 2131551, 2131578, 2136767, 2138024,
2131584, 2136762, 2131568, 2131564, 2132288, 2138063,
2132282, 2138054, 2138141, 2138072, 2132289, 2138123,
2138136, 2138112, 2136761, 2138073, 2138075, 2138133,
2131581, 2131598, 2131574, 2138137, 2138120, 2131595,
2131592;
b) Units: 2134620, 2135423, 2124484, 0956778, 0956791,
2139708, 0956816, 2138563, 2129694, 0956809, 2124442,
0956780, 2138008, 2139709, 2124524, 2135538, 2135543,
2139278, 2128818, 2139901, 2139844, 2133716, 2129663,
2138418, 2139666, 2140938, 2131150, 2131141, 2135216,
2135312, 2131395, 2134931, 2132203, 2136492, 2131491,
2134445, 2135399, 2133511, 2132250, 2132269, 2138337,
2132409, 2138390, 2140088, 2140892, 2132491, 2133706,
2138816, 2138423, 2132501, 2140964, 2132755, 2132750,
2132512, 2132502, 2140149, 2132493, 2133455, 2131471,
2133698, 2133787, 2133458, 2135545, 2139355, 2134771,
2133699, 2133360, 2138440, 2133632, 2133759, 2133773,
2138429, 2132486, 2134465, 2135144, 2131514, 2131511,
2134626, 2134644, 2134705, 2135425, 2134670, 2140945,
2140151, 2140896, 2134801, 2136670, 2136446, 2133466,
2135531, 2136269, 2138358, 2138363, 2140876, 2136684,
2136944, 2136920, 2136720, 2136919, 2136914, 2136911,
2135496, 2136952, 2139956, 2135993, 2135990, 2137827,
2137804, 2138559, 0956777, 2138217, 2139639, 2138351,
2138305, 2133299, 2140009, 2138355, 2132418, 2132427,
2132411, 2138385, 2133603, 2133658, 2138424, 2138413,
2133727, 2139682, 2138589, 2138474, 2139833, 2140131,
2140969, 2138542, 2132777, 2134865, 2135374, 2138544,
2138567, 0956806, 2139947, 2138302, 2139008, 2140951,
2140933, 2139224, 2135991, 2133207, 2124522, 2139250,
2135551, 2133938, 2139335, 2139274, 2138579, 2138426,
2133776, 2139332, 2132618, 2133212, 2133711, 2139691,
2138529, 2133932, 2139697, 2138591, 2137824, 2134446,
2139722, 2138597, 2138422, 2133780, 2139879, 2139923,
2139933, 2132766, 2139997, 2133930, 2133928, 2135276,
2140067, 2136250, 2136252, 2139627, 2140085, 2140897,
2140882, 2140903, 2140904, 2139026, 2140948, 2140956,
2140909, 2140872, 2132767, 2133464, 2140996, 2136870,
2135467, 2136680, 2139719, 2136756, 2139249, 2139952,
2138439;
c) Units: 2102657, 2102796, 2103869, 2103855, 2103828,
2103876, 2103878, 2103893, 2104239, 2104237, 2104233,
2104248, 2102696, 2138352, 2104645, 2102789, 2104247,
2102724, 2102762, 2102692, 2102668, 2102795, 2103883,
2102703, 2102794, 2102790, 2100593, 2104707
RECALLING FIRM/MANUFACTURER
Bergen Community Regional Blood Center, Paramus, NJ, by fax and letter on September 30, 2005. Firm initiated recall is complete.
REASON
Blood products, stored at a temperature above - 18º C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
NJ and NY

______________________________
PRODUCT
Recovered Plasma, Recall # B-1647-6.
CODE
Unit: 4119504
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile dated January 20, 2005. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of cancer, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Vienna, Austria
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

______________________________
PRODUCT
a) Terumo Advanced Perfusion System 1 Roller Pump
6 inch diameter, Catalog No. 801041, Recall # Z-1403-06;
b) Terumo Advanced Perfusion System 1 Roller Pump
4 inch diameter, Catalog No. 801040, Recall # Z-1404-06;
c) Terumo Advanced Perfusion System 1 Integrated Centrifugal
System Control Unit, Catalog No. 801046, Recall # Z-1405-06
CODE
a) Serial numbers 0033 through 1263;
b) Serial numbers 0031 through 1025;
c) Serial numbers 0020 through 0216
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems Corp., Ann Arbor, MI, by letter dated June 30, 2006. Firm initiated recall is ongoing.
REASON
The manual roller pump speed control knob may fail to function/change pump speed.
VOLUME OF PRODUCT IN COMMERCE
44,452 units
DISTRIBUTION
Nationwide and Internationally
______________________________
PRODUCT
a) Steris Amsco Sonic Energy Cleaner, Part Nos.:
P080000005, B018905020, B018905JBJ, and
B018905JBJSS, Recall # Z-1407-06;
b) Amsco Sonic Energy Console, Part Nos.: B602047470,
P080000002, P080000003, B018905015, B018905016,
B018905017, B018905018, B018905JAE, B018905JAESS,
B018905JAESSI, B018905JAG, B018905JAGSS,
Recall # Z-1408-06.
CODE
All units bearing serial numbers 0432000018 to 0403105051.
RECALLING FIRM/MANUFACTURER
Steris Corporation, Montgomery, AL, by letter on June 22, 2006. Firm initiated recall is ongoing.
REASON
Smoke, sparking and fire hazard -- Units manufactured between November 2000 and January 2005 are susceptible to water damage at the lid switch cable wiring harness, which may result in smoking, sparking and fire.
VOLUME OF PRODUCT IN COMMERCE
675 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
INOvent, Nitric Oxide Delivery System, Model Number 1605-9000-000, Recall # Z-1410-06.
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: INO Therapeutics, Inc., Clinton, NJ, by letter on July 5, 2005 and by email and telephone on July 7, 2006.
Manufacturer: Datex -- Ohmeda, Inc., Madison, WI. Firm initiated recall is ongoing.
REASON
The Kel-F Tip mounted on the high pressure hose can become dislodge/lodged in the INOmax valve outlet.
VOLUME OF PRODUCT IN COMMERCE
3,123 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Zimmer Trabecular Metal Reverse Shoulder System
Glenosphere, 36 mm diameter, Catalog/Ref No.
00-4349-036-01, Recall # Z-1416-06;
b) Zimmer Trabecular Metal Reverse Shoulder System
Glenosphere, 40 mm diameter, Catalog/Ref No.
00-4349-040-04, Recall # Z-1417-06;
c) Zimmer Trabecular Metal Reverse Shoulder System
Base Plate; Catalog/Ref No. 00-4349-038-00,
Recall # Z-1418-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated July 20, 2006.
Manufacturer: Zimmer Trabecular, Allendale, NJ. Firm initiated recall is ongoing.
REASON
Components may not lock together as intended.
VOLUME OF PRODUCT IN COMMERCE
197 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, Recall # Z-1419-06.
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioCare Systems, INC., Parker, CO, by telephone beginning June 8, 2006, followed by a letter on June 23, 2006.
Manufacturer: Cui Stack, Inc., Beaverton, OR. Firm initiated recall is ongoing.
REASON
Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard.
VOLUME OF PRODUCT IN COMMERCE
175 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Guardian Walker, Models 30751W, 30757W, 30758W,
Recall # Z-1420-06;
b) Guardian 5 inch Walker Wheel Kits, Model Numbers:
07722-8, 07722G, 07722-5, 07722-8B, 07725, Recall # Z-1421-06.
CODE
a) and b) Lots: 0603, 0604, 0605
RECALLING FIRM/MANUFACTURER
A & E Industries, Ltd., Guangdong, Chin, by letter on June 30, 2006. Firm initiated recall is ongoing.
REASON
Walker wheel hubs may fracture, causing walker to collapse to one side.
VOLUME OF PRODUCT IN COMMERCE
175 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
a) Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile,
(Standalone Systems) Catalog Numbers 050255500, 050316400,
050412400, 050500000, Recall # Z-1422-06;
b) Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile,
(Standalone systems). Catalog Numbers: 050226400, 050422400,
Recall # Z-1423-06;
c) Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile,
(Standalone systems), Catalog numbers:050125400, 050502000,
Recall # Z-1424-06;
d) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile,
(Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001,
067129002, 067149006, 067174002, 067188002, 067212004, 067221009,
067236004, 067260001, 067296002, 067351006, 067354002, 067388004,
067434005, 067442001, 067447010, 067452001, 067458005, 067481003,
06748002, 067523001, 067529002, 067536002, 067539005, 067570003,
067577001, 067594003, 067602001, 067614005, 067625001, 067634005,
067662002, 067668001, 067682001, 067683003, 067686005, 067694002,
067709001, 067710001, 067714001, 067721002, 067722001, 067735002,
078011601, 078011701, 078014002, 078107009, 078149017, 078183015,
078196012, 078249006, 078280017, 078346013, 078351010, 078399009,
078439012, 078522010, 078534012, 078541004, 078549011, 078574008,
078707005, 078766004, 078892004, 078898003, 078909002, 0789337004,
078959005, 078987001, 078988002, 07896006, Recall # Z-1425-06;
e) Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile,
(Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103,
078005802, 078159025, 078201013, 078212009, 078310006, 078332022,
078348014, 078428010, 078688007, 078869003, Recall # Z- 1426-06;
f) Cobe Optimin Hollow Fiber Sealed System, Sterile,
(Custom Heart / Lung Pack), Catalog Numbers: 067350004,
067734001, 067736002, Recall # Z-1427-06;
g) Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile,
Catalog Number 436422974, (shipped International only for use in
Heart/Lung packs), Recall # Z-1428-06;
h) Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile,
Catalog Number: 436122974, (shipped international only for use in
Heart/Lung Packs), Recall # Z-1429-06.
CODE
a) Lot Numbers 0608000009, 0610800078, 0613600057;
Lot Numbers 0607300017, 0608000011, 0608700110, 0608800063,
0609400137, 0610100174, 0610200062, 0610800080, 0611600081,
0612200144, 0612900020, 0612900039, 0613600059.;
Lot Number 0608000010, 0608700109, 0609400136, 0610800079,
0611600080, 0612200143, 0612900038, 0613000001;
Lot Number 0609400138, 0610100176, 0611600082, 0612200146;
b) Lot Numbers: 0607300026, 0609400146, 0610100183, 0611600089,
0612200155, 0612900044,
Lot Numbers: 0607300025, 0608000018, 0608700122, 0610800088;
c) Lot Numbers: 0610800081, 0613600060, 0614400061, Lot number 0612200145;
d) Serial numbers: 0609400012, 0609400029, 0611500069, 0611500082, 0612800162,
0614300012, 0614300033, 0610800032, 0612800057, 0613600155, 0611500073,
0614300014, 0612200082, 0612200097, 0613600017, 0611500011, 0612800111,
0611500037, 0613500120, 0615000130, 0610100013, 0610100022, 0610100023,
0611500012, 0611500022, 0611500023, 0611500024, 0611500074, 0613600044,
0611600153, 0614200056, 0610100063, 0612800086, 0615000047, 0615000057,
0612200035, 0610100082, 0611500014, 0613500121, 0614300045, 0612200011,
0613500075, 0613500076, 0615000049, 0611500099, 0613500097, 0613500104,
0614300067, 0612800142, 0612200058, 0615200006, 0612400011, 0611500038,
0612200012, 0614200088, 0612200059, 0614300017, 0611500015, 0615000099,
0612200036, 0610800019, 0615000133, 0612800143, 0615000051, 0612200061,
0615000100, 0613600046, 0614300068, 0612200038, 0613800007, 0614300001,
0610100084, 0614300018, 0612200014, 0612200126, 0612800089, 0615000073,
0612800168, 0610900041, 0613100004, 0610900044, 0612800090, 0613600021,
0610800116, 0612200084, 0615000074, 0612200016, 0612800144, 0611500100,
0612800145, 0611500039, 0612800068, 0612400007, 0614200090, 0609400054,
0610100042, 0611500040, 0613600022, 0610800048, 0610800117, 0612200086,
0613600023, 0609400055, 0611500041, 0612800091, 0615000052, 0609400129,
0610100103, 0610700029, 0608900036, 0608900037, 0615200007, 0612900006,
0610100104, 0613800003, 0614300046, 0609400057, 0609400167, 0611500076,
0609400058, 0613600025, 0615000075, 0612200017, 0610100085, 0610100043,
0611600119, 0610100087, 0614300021, 0609400093, 0612200064, 0610800118,
0614300022, 0609400059, 0611500118, 0610100067, 0610100071, 0613100005,
0613100006, 0608700021, 0610100088, 0612800115, 0612200042, 0612200049,
0612200019, 0614300072;
e) Serial numbers: 0614200085, 0610800149, 0612800146, 0614200089,
0610800022, 0612800069, 0614300069, 0609400089, 0609400102,
0609400103, 0610800049, 0612800114, 0612800125, 0612800126,
0609400091, 0614200058, 0614200069, 0610800151, 0614300071,
0609400130, 0611500101, 0614200059, 0613500077, 0613500083,
0612200040, 0614200060, 0612200063, 0614300020, 0612800074,
0610100066, 0612200065;
f) Lot Numbers: 0610100039, 0612800087, 0615000071;
Lot Number 0614400151; Lot numbers: 0608700018, 0612200085;
g) Lot number 0610800082;
h) Lot numbers: 0611600091, 0613600069.
RECALLING FIRM/MANUFACTURER
Recalling Firm: COBE Cardiovascular, Inc, Arvada, CO, by Letter on June 26, 2006.
Manufacturer: Senior Operations, Inc., Bartlett, IL. Firm initiated recall is ongoing.
REASON
Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metallic material, thus decreasing the surface area needed for proper heat transfer.
VOLUME OF PRODUCT IN COMMERCE
9,053 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Mallinckrodt Satin-Slip Intubation Stylet, 6 Fr., single use, shipped in cases of 20, Model number 85863, Recall # Z-1431-06.
CODE
All lot codes beginning in 05 and 06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nellcor Puritan Bennett, Pleasanton, CA, by letters on July 12, 2006.
Manufacturer: MMJ S. A. de C.V., Cd Juarez, Mexico. Firm initiated recall is ongoing.
REASON
Product's outer sheath material may separate from the wire interior during use and may lodge in the endotracheal tube or enter the patient's airway and interfere with ventilation.
VOLUME OF PRODUCT IN COMMERCE
30,366 cases with 20 units each
DISTRIBUTION
Nationwide, Guam and Japan

______________________________
PRODUCT
a) ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Fenestrated
(Duckbill) Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1008.
The product is distributed sterile in heat-sealed tray and labeled with an
expiration date that pertains only to the sterility, Recall # Z-1433-06;
b) ConMed DetachaTip Multi-Use Laparoscopic Instrument, "Endoweave
Multiple Use Grasper", 5 mm x 33 cm, REF/Product code-1-1028.
The product is distributed sterile in heat-sealed tray and labeled with an
expiration date that pertains only to the sterility, Recall # Z-1434-06
CODE
a) All lot codes manufactured between October 20, 2003 and February
16, 2005. Each lot code is found on the package labeling of unopened
units and is also embossed on the gray hub of the device. For 5 digit
lot codes: the 1st digit represents the year (4 represents 2004), the 2nd
& 3rd digits represent the month (09 for September), and the 4th * 5th
digits for the day of the month. For 7 digit lot codes: the 1st two digits
represent the year, the 3rd & 4th represent the month, the 5th & 6th
represent the day of the month, and the 7th digit represents the
manufacturing shift code;
b) All lot codes manufactured between October 6, 2003 and February
14, 2005. Each lot code is found on the package labeling of unopened
units and is also embossed on the gray hub of the device. For 5 digit
lot codes: the 1st digit represents the year (4 represents 2004), the 2nd
& 3rd digits represent the month (09 for September), and the 4th * 5th
digits for the day of the month. For 7 digit lot codes: the 1st two digits
represent the year, the 3rd & 4th represent the month, the 5th & 6th
represent the day of the month, and the 7th digit represents the
manufacturing shift code.
RECALLING FIRM/MANUFACTURER
Conmed Corporation, Utica, NY, by letters dated March 27, 2006, by facsimile and/or e-mail. Firm initiated recall is ongoing.
REASON
Grasper jaws breaking at the junction of the jaw and tube during Laparoscopic procedures.
VOLUME OF PRODUCT IN COMMERCE
8,702 units
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope, MicroVision Medical brand, Recall # Z-1435-06.
CODE
Lot number: 583546
RECALLING FIRM/MANUFACTURER
MicroVision Medical Holding B.V., Amsterdam, Netherlands, by letter dated July 21, 2006. Firm initiated recall is ongoing.
REASON
Some lenses may have microscopic holes in the disposable caps representing a potential break in the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE
540 caps
DISTRIBUTION
Nationwide and Internationally
 

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

______________________________
PRODUCT
Focusâ * DAILIESâ * Toric * One-Day Contact Lenses * CIBA Vision, Recall # Z-1402-06.
CODE
Lot # 6118348 (5 pack), 6110170 (30 pack) and 6110210 (30 pack).
RECALLING FIRM/MANUFACTURER
Ciba Vision Corporation, Duluth, GA, by letter on July 25, 2006. Firm initiated recall is ongoing.
REASON
Misbranding; Lenses (-0.75) are labeled with the incorrect power of (-1.50).
VOLUME OF PRODUCT IN COMMERCE
86 packs (approx. 1,000 lenses)
DISTRIBUTION
Nationwide

______________________________
PRODUCT
D7120, BG-OX Cartridge, D7120 REF 946-003, cuvettes for the NPT7 series of blood gas analyzers, Recall # Z-1406-06.
CODE
Lot: R0187, Expiration Date: Sept. 2005
RECALLING FIRM/MANUFACTURER
Recalling Firm: Radiometer America, Inc., Westlake, OH, by letter dated January 12, 2005.
Manufacturer: Radiometer Medical ApS, Bronshoj, Denmark. Firm initiated recall is ongoing.
REASON
QC Bias-a solution used in the manufacturing of the membrane had a different composition which introduces a bias of 20 mpH.
VOLUME OF PRODUCT IN COMMERCE
545 units
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Lp(a) Calibrator, Catalog No. 998-41491, 1 ml glass bottles, in cardboard box, 2 bottles/box, Recall # Z-1409-06.
CODE
Lot numbers: EK560, Exp 7/31/06 and EH213, Exp 9/30/06.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wako Chemicals, USA Inc., Richmond, VA, by telephone and e-mail letter dated July 6, 2006.
Manufacturer: Wako Pure Chemical Industries Ltd., Osaka, Japan. Firm initiated recall is ongoing.
REASON
Unexpected low cholesterol results. The Cholesterol calibrator (Lp(a)) component of the in vitro diagnostic kit for cholesterol testing, has provided patient results lower than the correct value.
VOLUME OF PRODUCT IN COMMERCE
135 kits
DISTRIBUTION
Nationwide

______________________________
PRODUCT
a) Joerns Easy Care 2000, Model B784, Manual adjustable
Hospital Bed, Recall # Z-1411-06;
b) Joerns Easy Care 2003 bed, Model B684,
Joerns Easy Care 2003 DC bed, Model B684DC,
Joerns Easy Care 2100, Model B694 AC-powered adjustable
Hospital Bed, Recall # Z-1412-06.
CODE
a) Serial numbers: 100104, 100604, 101804, 101904, 102004,
102204, 102504, 102604, 102704, 102904, 120804;
b) Serial numbers: 101204, 101804, 101904, 102004, 102104,
102204, 102504, 102604, 102804, 102904, 110104, 111204,
and 113004.
RECALLING FIRM/MANUFACTURER
Sunrise Medical CCG, Inc., Stevens Point, WI, by telephone on November 16, 2005. Firm initiated recall is complete.
REASON
Malfunction. The Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional.
VOLUME OF PRODUCT IN COMMERCE
666 beds
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Tubing Set for TEM-Combined System, the tube set consists of a rectal pressure measuring tube, an insufflation tube, an irrigation tube, a suction tube, a pump tube, and a connection tube, a sterile, disposable, single use accessory to the TEM (Transanal Endoscopic Microsurgery) System used for insufflation of the rectal cavity. Part number: 4170.801, Recall # Z-1430-06.
CODE
Lot number: 060232, EXP. 2011-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Richard Wolf Medical Instruments Corp., Vernon Hills, IL, by telephone on July 7, 2006.
Manufacturer: V. Krutten Gmbh, Idstein, Germany. Firm initiated recall is ongoing.
REASON
The irrigation tubing in the tube set was assembled incorrectly with the connectors reversed.
VOLUME OF PRODUCT IN COMMERCE
100 sets
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Active Life Non-Convex Drainable Stomahesive pouch-1 ¼" (32 mm), Product No. 022766, UPC: 30003-022766, Recall # Z-1432-06
CODE
Lot: 5H0436N
RECALLING FIRM/MANUFACTURER
ConvaTec, Skillman, NJ, by letter, on July 13, 2006. Firm initiated recall is ongoing.
REASON
Cartons labeled 1-1/4 inch size may contain units that are 1-1/2 inch size.
VOLUME OF PRODUCT IN COMMERCE
3,857 market units
DISTRIBUTION
Nationwide


END OF ENFORCEMENT REPORT FOR AUGUST 30, 2006

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