Coloplast Conveen Urine Collection Leg Bag Recalled for Seam Leakage
Coloplast is recalling Conveen Urine Collection Leg Bags due to potential leakage from the bag seam when filled.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a functional defect (leakage) in a medical device that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Coloplast Manufacturing US, LLC is recalling the Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. The recall involves 217,540 units distributed nationwide, including Puerto Rico and 32 states.
The recall is being conducted due to potential leakage from the bag seam when the bag is filled. This defect may compromise the integrity of the urine collection system.
Consumers should stop using the affected leg bags and contact Coloplast for further instructions or a replacement. The affected lot numbers are listed in the official recall documentation.
The recalled product
- Product
- Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.
- Manufacturer
- Coloplast Manufacturing US, LLC
- Hazard
- Affected units
- 217,540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 3880261
- 3880268
- 3932929
- 3932933
- 3940329
- 3940332
- 3949825
- 3949828
- 3968997
- 3969002
- 3997492
- 3997778
- 3997782
- 4006822
- 4019572
- 4019574
- 4047072
- 4047075
- 4056422
- 4056423
Distribution
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