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Aspen® Flexible Light Handle Adapter

ASPEN SURGICAL PRODUCTS, INC. · Model LT-9534X · UDI-DI 00887761008649

FAT
8
510(k) clearances
36
Adverse events
2
Recalls
8
Facilities

Description

Intent to be used with Aspen Surgical Disposable light Handle covers.

Recalls

DateFirmReason
2010-05-11Stryker EndoscopyThe silicone sheath component of the product detaches from the catheter upon removal of the e-kit from the body.
2009-08-20Stryker EndoscopyThe silicone sheath component of the product detaches from the catheter during removal of the e-kit from the body.

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Data 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.