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Coulmed
Coulmed Products Group LLC · Model A5010 · UDI-DI 10810087350489
0
510(k) clearances
37
Adverse events
2
Recalls
96
Facilities
Description
Urology Drain Collection Bag: 5-Gallon Capacity, Built in Handles, Connection tube/hose included
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-02-24 | Purewick Corporation | PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the p |
| 2014-09-29 | Coloplast Manufacturing US, LLC | Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.