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

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case — recall Z-0134-2020

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-0134-2020
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): 163840455

Reported risk: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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.

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case — recall Z-0134-2020

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