Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2191-2015 — American Catheter / Cholangiogram Catheter 9100 Series.

U.S. FDA — Device Enforcement · United States · 2015-03-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2191-2015
Date of alert
2015-03-17
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
American Catheter Corp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14101601
Reported risk: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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