FDAFDA · Food and drugs·Recall number Z-1567-2023
ASM Replacement Battery, Component Number SUB0000864
Published May 24, 2023 · Recall initiated: March 22, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical Inc
- Distributor
- worldwide
- Lot
- Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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