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

Recall Z-0359-2023 — Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient

U.S. FDA — Device Enforcement · United States · 2022-11-01 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0359-2023
Date of alert
2022-11-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Cardinal Health
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10884521009455
Reported risk: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention
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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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.