Plum 360 Infusion Battery Recall Due to Manufacturing Defect
ICU Medical is recalling Plum 360 Infusion System replacement batteries due to a manufacturing defect that may cause loss of capacity and decreased runtime earlier than expected. Approximately 11,961 units were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class I, which requires a minimum severity score of 4. Although no illnesses have been reported, the FDA's Class I classification indicates the agency's determination that there is reasonable probability the product could cause serious adverse health consequences.
Plain-English summary
ICU Medical Inc is recalling replacement batteries (List Number SUB0000864) for the Plum 360 Infusion System due to a manufacturing defect.
The batteries may experience a loss of capacity earlier in the battery lifecycle than expected, and overall battery runtime may decrease earlier than expected. This defect originates from the battery supplier.
A total of 11,961 units were distributed worldwide, including the United States and 18 other countries: Australia, Canada, France, Guadeloupe, Guatemala, Ireland, Italy, Oman, Paraguay, Qatar, Spain, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Uruguay.
The recalled product
- Product
- Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed with the following descriptions: Bomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Inf
- Manufacturer
- ICU Medical Inc
- Hazard
- battery-degradation
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 43414565)
- +M33530010041311 (43422532
- 43511323
- 43418697
- 43419090
- 43429221
- 43419323
- 43418389
- 43418094
- 43419257
- 43429686
- 43429767
- 43429677
- 43419283
- 43429566
- 43419102
- 43429724
- 43429718
- 43429710
- 43429707
Distribution
Distributed nationwide across the United States.
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