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

Recall Z-1047-2024 — Dover" HYDROGEL COATED LATEX 400 ML U/M FOLEY TRAY, LL, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 16FR (5.3 MM), 5CC, CSD; Dover" 100% SILICONE SILVER-HYDROGEL COATED 400ML U/M TEMP SENSE FOLEY TRAY, 18FR (6.0 MM), 5CC

U.S. FDA — Device Enforcement · United States · 2023-12-04 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1047-2024
Date of alert
2023-12-04
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Cardinal Health 200, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20884521066950
Reported risk: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
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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