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Absorbent Kit
HURRICANE MEDICAL INC · Model 9803 · UDI-DI 00813465012224
HOZ
Prescription
1
510(k) clearances
62
Adverse events
10
Recalls
74
Facilities
Description
Each kit contains one 9101 Instrument Wipe, one 9802 Fluid Wick, one 9202 Corneal Light Shield, all used for fluid absorption during eye surgery.
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.