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Merocel
Beaver-Visitec International, Inc. · Model 400108 · UDI-DI 30886158012000
HOZ
Prescription
10
510(k) clearances
62
Adverse events
10
Recalls
74
Facilities
Description
Wick with 80cc Collection Bag
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2024-10-22 | Carwild Corporation | Potential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product. |
| 2022-12-20 | Beaver Visitec International, Inc. | Device packaging may contain open seals, compromising product sterility. |
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0 |
| 2013-08-12 | DeRoyal Industries Inc | One lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product. |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
| 2003-01-08 | Ultracell Medical Technologies | Sterility of the device is compromised |
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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.