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

Recall Z-1975-2019 — RUSCH Urinary Drainage bag, 2000mlm REF 390060 urine collection device

U.S. FDA — Device Enforcement · United States · 2019-01-14 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1975-2019
Date of alert
2019-01-14
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Teleflex Medical
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14026704645715
Reported risk: The device labels are not UDI compliant. The missing UDI compliance information on the labelling would not affect the function/performance of the device itself. Other label information and warnings are unaffected by this labelling.
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.