PlainRecalls
FDA Devices Critical Class I Ongoing

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

Reported: May 24, 2023 Initiated: March 22, 2023 #Z-1565-2023

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.

Details

Recalling Firm
ICU Medical Inc
Units Affected
28656 units
Distribution
worldwide
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled?
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Recalled by ICU Medical Inc. Units affected: 28656 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 24, 2023. Severity: Critical. Recall number: Z-1565-2023.