Device product
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Z-0155-2015
Product summary
- Event
- Event 69412
- Status
- Terminated
- Classification
- Class II
- Quantity
- 217,540
- Official record key
device-enforcement:Z-0155-2015
Official wording
Reason: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.