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

Recall Z-2448-2024 — Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 11973. OUS units marketed with the following descriptions: Plum A+ Mednet TM Firmware New 13.6 Span, Plum A+3,

U.S. FDA — Device Enforcement · United States · 2024-05-07 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2448-2024
Date of alert
2024-05-07
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
ICU Medical Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
206782284
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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