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

Recall Z-0337-2026 — ICU Medical Oncology Transfer Kit w/ChemoClave and ChemoLock Port; Spiros w/Red Cap; ChemoLock Port REF: CL4138

U.S. FDA — Device Enforcement · United States · 2025-09-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0337-2026
Date of alert
2025-09-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
10887709096131
Reported risk: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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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