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Flyte, SurgiCool
STRYKER CORPORATION · Model 0408801500 · UDI-DI 07613252661085
FXY
Prescription
10
510(k) clearances
51
Adverse events
3
Recalls
24
Facilities
Description
Peel-Away Hood
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-20 | O&M HALYARD, INC. | Product was mislabeled as a Surgical Cap at its dispenser level. |
| 2005-09-13 | VIASYS Med Systems | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. |
| 2005-09-13 | VIASYS Med Systems | The packaging may be compromised such that sterility of the hoods cannot be guaranteed. |
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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.