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

Recall Z-2721-2024 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

U.S. FDA — Device Enforcement · United States · 2024-08-01 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2721-2024
Date of alert: 2024-08-01
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Fresenius Kabi USA, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00811505030054

Reported risk: A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).

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.

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.

Recall Z-2721-2024 — LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.

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