Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
- Company
- Coloplast Manufacturing Us, Llc
- Recall Initiated
- September 29, 2014
- Posted
- October 30, 2014
- Terminated
- March 10, 2015
- Recall Number
- Z-0155-2015
- Quantity
- 217,540
- Firm Location
- Minneapolis, MN
Reason for Recall
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Distribution
Nationwide 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.
Lot / Code Info
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.
Root Cause
Process control
Action Taken
Consignees 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.