FDA Device recall Z-1568-2023
ASM Replacement Battery, Component Number SUB0000594
- FDA Device
- Class I
- ongoing
- Published 2023-05-24
On 2023-05-24 the FDA classified a Class I recall of ASM Replacement Battery, Component Number SUB0000594 by Icu Medical, citing 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 ru….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1568-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-03-22 |
| Published | 2023-05-24 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Icu Medical |
| Distribution | n/a |
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.
Identifiers
| code_info | Lot Numbers: 5660479 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1568-2023%22
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