—#199476

Product

ASM Replacement Battery, Component Number SUB0000864

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

ICU medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 03/22/2023 to its direct and indirect consignees by mail. The notice explained the issue and the hazard and requested the following: Clinical Users: Whenever possible, keep the pump plugged into AC power. Before disconnecting the pump from AC power, please ensure that the battery is fully charged. Closely monitor the Battery Status Indicator while the pump is disconnected from AC power. Additionally, have a backup pump available when infusing critical medications. Biomedical Engineering: You may replace affected batteries with a new CSB battery until corrected batteries are available. Please do not use a replacement battery with corroded battery terminals. 1. Identify all affected batteries in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and proposed mitigations. 2. Complete and return the attached Response Form to icumedical5967@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical5967@sedgwick.com.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: worldwide

Timeline

Recall initiated: 2023-03-22
Posted by FDA: 2023-05-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #199476. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.