Recall Z-0155-2015— Coloplast Manufacturing US, LLC
Class II · Terminated
Class II FDA medical device recall by Coloplast Manufacturing US, LLC, initiated 2014-09-29, terminated 2015-03-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.. Reason: Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled..
- Recalling firm
- Coloplast Manufacturing US, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-29
- Terminated
- 2015-03-10
- Firm location
- Minneapolis, MN, United States
Product description
Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
Reason for recall
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.