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Convenience Bag
TYPENEX MEDICAL LLC · Model 7000HPE · UDI-DI 00810050854252
9
510(k) clearances
12
Adverse events
1
Recalls
224
Facilities
Description
Convenience Bag with Hand Protection, EU (White)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-30 | DeRoyal Industries Inc | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. |
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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.