FDA Device Recall Z-1565-2023

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

Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010

Lot / serial / GTIN: All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower

Quantity: 28656 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-1565-2023
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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