Recall Z-0137-2020— 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 Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches 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 Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches 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.