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

Recall Z-0858-2024 — Cardinal Health Monoject, 1 mL Purple Enteral Syringe with Enfit Connection Sterile, REF 401SE

U.S. FDA — Device Enforcement · United States · 2023-12-28 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0858-2024
Date of alert
2023-12-28
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)
26971564466206
Reported risk: Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts.
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.