FDAFDA · Food and drugs·Recall number Z-2449-2024
Plum 360/A+ spare batteries. Item Number: SUB0000864.
Published August 21, 2024 · Recall initiated: May 7, 2024
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 Distribution: US (nationwide) and OUS (foreign) countries of: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
- Lot
- Item Number: SUB0000864; Lot Numbers: 13620902, 13588166, 13651642, 13651688, 13651686, 13651685, 13492940, 13498252, 13498259, 13716418, 13716411, 13651680, 13620909, 13716514, 13588168, 13594285, 13620897, 13638726, 13620893, 13594289, 13638724, 13651671, 13594281, 13620898, 13659496, 13638723, 13594280, 13638728, 13588163, 13588169, 13588170, 13651640, 13638727, 13618384, 13769263, 13588165, 13588161, 13716427, 13570187, 13765276, 13651678, 13746712, 13749803, 13771023, 13771500, 13716336, 13588159, 13716329, 13594286, 13594287, 13620905, 13651677, 13594282.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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