Recall Z-1568-2023— ICU Medical Inc
Class I · Ongoing
Class I FDA medical device recall by ICU Medical Inc, initiated 2023-03-22. FDA's recall record names no specific 510(k) clearance for this event. Product: ASM Replacement Battery, Component Number SUB0000594. Reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected..
- Recalling firm
- ICU Medical Inc
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-03-22
- Firm location
- Lake Forest, IL, United States
Product description
ASM Replacement Battery, Component Number SUB0000594
Reason for recall
Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.
Data sourced from openFDA. This site is unofficial and independent of the FDA.