FDAClass IMay 24, 2023

Replacement Battery List Number SUB0000594 found in recall

Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e)…

Why was Replacement Battery List Number SUB0000594 found in 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower

Product
Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 11971, c) 12391, d) 12618, e)…
Recalling firm
ICU Medical Inc
Quantity
23815 units
Distribution
worldwide
Recall date
May 24, 2023
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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