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

Recall Z-0010-2013 — 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

U.S. FDA — Device Enforcement · United States · 2012-09-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0010-2013
Date of alert: 2012-09-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: C.R. Bard, Inc., Urological Division
Product category: device
Product type: Devices

Reported risk: The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

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.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0010-2013 — 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

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