Z-1565-2023 Class I Ongoing
FDA device recall Z-1565-2023 was initiated by ICU Medical Inc on March 22, 2023 and is designated Class I. 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 ea… The recall status is ongoing. Affected quantity: 28656 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 24, 2023
- Initiation Date
- March 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 28656 units
Product Description
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
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.
Distribution Pattern
worldwide
Code Information
All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower