Medline Medical Convenience Kits Recalled for Catheter Sterility Issue
Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.
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: FDA Class II medical device recall for a potential sterility issue in catheter components. The hazard is theoretical, detected during testing rather than through reported adverse events, with no illnesses or injuries mentioned in the source material.
Plain-English summary
Medline Industries is recalling medical convenience kits (model DUNJ63397, lot numbers 22HLA247, 21HLA443, 21JLA520, 22GLA335) that were assembled with specific Coloplast Foley catheters and prostatic catheters. The catheters included in these kits were previously recalled due to a potential sterility issue identified during testing.
A non-sterile catheter could expose patients to infection risk if used in medical procedures. The kits are distributed in California, with 36 units involved in this recall.
Healthcare facilities and patients who received affected kits should discontinue use immediately. Contact Medline Industries for replacement or return of the affected units. Verify your inventory against the lot numbers (22HLA247, 21HLA443, 21JLA520, 22GLA335) to identify any affected kits.
The recalled product
- Product
- Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 36
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 (5)
- UDI/DI 10193489736755 (ea) 40193489736756 (cs)
- Lot Numbers: 22HLA247
- 21HLA443
- 21JLA520
- 22GLA335.
Distribution
Distributed in 1 state:
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