FDA Device Recall Z-1567-2023

ICU Medical Inc · Lake Forest, IL

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

ASM Replacement Battery, Component Number SUB0000864

Lot / serial / GTIN: Lot Numbers: 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757

Quantity: 9984 units

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.

Recall record

Recall number: Z-1567-2023
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: worldwide
Recall initiated: 2023-03-22
Classified by FDA Center: 2023-05-16
FDA published: 2023-05-24
Recalling firm: ICU Medical Inc
Firm location: Lake Forest, IL

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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