Recall Z-0131-2020— ICU Medical Inc
Class II · Terminated
Class II FDA medical device recall by ICU Medical Inc, initiated 2019-07-29, terminated 2024-01-12. It names one FDA 510(k) clearance: K171346. Product: Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case. 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
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case
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.