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

Recall Z-0703-2021 — 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Hanger, REF: CL3011; 31" (79 cm) Appx 3.4 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chamber, Spiros w/Red Cap, Bag Hanger, REF: CL3011T; 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock w/Red Cap

U.S. FDA — Device Enforcement · United States · 2020-08-31 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0703-2021
Date of alert
2020-08-31
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical, Inc.
Product category
device
Product type
Devices
Reported risk: Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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