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

Recall Z-1037-2019 — Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted inte

U.S. FDA — Device Enforcement · United States · 2019-01-09 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1037-2019
Date of alert: 2019-01-09
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: ConvaTec, Inc
Product category: device
Product type: Devices

Reported risk: An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

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.

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