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

Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 16 FR (5.3 MM), 5 CC, 2000 ML DRAIN BAG; Dover" 100% SILICONE 400 ML U/M FOLEY TRAY, COUD¿ TIP, 18 FR (6.0 MM), 5 CC, 2000 ML DRAIN BAG; Dover" HYDROGEL COATED LATEX FOLEY TRAY, LUER LOCK, 16 FR (5.3 MM), 5 CC, 2000 ML BAG, DRAIN SPOUT; Dover" U — recall Z-1048-2024

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-1048-2024
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): 20884521174068

Reported risk: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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