Recall Z-0142-2020— ICU Medical Inc
Class II · Terminated
Class II FDA medical device recall by ICU Medical Inc, initiated 2019-07-29, terminated 2024-01-12. FDA's recall record names no specific 510(k) clearance for this event. Product: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.. Reason: Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets..
- Recalling firm
- ICU Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-07-29
- Terminated
- 2024-01-12
- Firm location
- Lake Forest, IL, United States
Product description
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.
Reason for recall
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Data sourced from openFDA. This site is unofficial and independent of the FDA.