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

Recall Z-1358-2016 — BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

U.S. FDA — Device Enforcement · United States · 2015-12-18 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1358-2016
Date of alert
2015-12-18
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
C.R. Bard, Inc.
Product category
device
Product type
Devices
Reported risk: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.
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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