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Recall Observatory FDA recall evidence

Device product

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

Z-0155-2015

September 29, 2014

Class II

Product summary

Firm
Coloplast Manufacturing US, LLC
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

    reason.no_named_rule · v1.0.0

    Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.