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

Recall Z-0135-2020 — Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

U.S. FDA — Device Enforcement · United States · 2019-07-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0135-2020
Date of alert
2019-07-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
ICU Medical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
240100401
Reported risk: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
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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