Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1565-2023 — Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

U.S. FDA — Device Enforcement · United States · 2023-03-22 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1565-2023
Date of alert
2023-03-22
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
ICU Medical Inc
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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