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

Recall Z-1241-2014 — SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the

U.S. FDA — Device Enforcement · United States · 2014-02-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1241-2014
Date of alert: 2014-02-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Convatec Inc.
Product category: device
Product type: Devices

Reported risk: The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.

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