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INSTRUMENT TRANSPORT BAG

CYGNUS MEDICAL L.L.C. · Model ITB1218-H · UDI-DI 00843356102413

GEJ
5
510(k) clearances
9
Adverse events
4
Recalls
72
Facilities

Description

INSTRUMENT TRANSPORT BAG 12'' x 18'', 2MIL RESEALABLE COMPOSTABLE BAG PRINTED W/ HIGH LEVEL DISINFECTED LABEL - 100 TRANSPORT BAGS PER CARRIER

Recalls

DateFirmReason
2017-04-25Cook Inc.reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2017-04-25Cook Inc.reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2017-04-25Cook Inc.reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
2006-10-12Conmed CorporationThe grasper jaws broke during laparoscopic procedures at the junction of the jaw and the tube.

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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.