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Aspen® Flexible Light Handle Cover
ASPEN SURGICAL PRODUCTS, INC. · Model FLEX02NS · UDI-DI 00840113209293
1
510(k) clearances
36
Adverse events
2
Recalls
9
Facilities
Description
Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-05-11 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body. |
| 2009-08-20 | Stryker Endoscopy | The silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body. |
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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.