PlainRecalls
FDA Devices Critical Class I Ongoing

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, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set

Reported: August 21, 2024 Initiated: May 7, 2024 #Z-2448-2024

Product Description

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, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set

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
14,744 units
Distribution
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.
Location
Lake Forest, IL

Frequently Asked Questions

What product was recalled? ▼
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, PLUM A+3 INFUSION PUMPS and Plum A+3 Wireless Refurb, PLUM A+, PLUM A+ Infusion System, PlumA+3IV Pump Multi 1' Set. Recalled by ICU Medical Inc. Units affected: 14,744 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 August 21, 2024. Severity: Critical. Recall number: Z-2448-2024.

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