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U.S. Department of Health and Human Services

Class 2 Device Recall Coloplast Conveen Urine Collection Leg Bag

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 Class 2 Device Recall Coloplast Conveen Urine Collection Leg Bagsee related information
Date Initiated by FirmSeptember 29, 2014
Date PostedOctober 30, 2014
Recall Status1 Terminated 3 on March 10, 2015
Recall NumberZ-0155-2015
Recall Event ID 69412
Product Classification Bag, urine collection, leg, for external use, non-sterile - Product Code NNW
ProductColoplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Code Information Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.
Recalling Firm/
Manufacturer		 Coloplast Manufacturing US, LLC
1601 W River Rd
Minneapolis MN 55411-3431
For Additional Information ContactColoplast Customer Service
800-533-0464
Manufacturer Reason
for Recall		Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
FDA Determined
Cause 2		Process control
ActionConsignees were sent a Coloplast "Recall Voluntary Notification " letter on 9-30-2014. The letter described the problem and the product affected by the recall. Requested consignees to complete the attached Acknowledgement Form and return to Coloplast or contact Coloplast Customer Service at 800-533-0464 to communicate the status of any product in their possession. If the product was distributed, they advised consignees to contact customers immediately and advise them of the recall and have them return the product to them. For questions they can contact Coloplast at Customer Service at 800-533-0464.
Quantity in Commerce217,540
DistributionNationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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