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

Recall Z-0865-2016 — Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices

U.S. FDA — Device Enforcement · United States · 2016-01-20 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0865-2016
Date of alert
2016-01-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cook Inc.
Product category
device
Product type
Devices
Reported risk: Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices.
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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