FDAFDA · Food and drugs·Recall number Z-0155-2015
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Published November 5, 2014 · Recall initiated: September 29, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Coloplast Manufacturing US, LLC
- Distributor
- 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
- 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.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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