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Critical recall: Death or serious injury has been reported or is considered likely. Stop using this product now.

ICU Medical Inc 2023-05-24 Health critical FDA
Health · FDA · Recall #FDA-Z-1565-2023

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

Issued May 24, 2023 · ICU Medical Inc

In May 2023, ICU Medical Inc recalled the Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.

Compiled by Maya Ellison, RecallCheckr

What this means for you

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 you should do

  1. 1 Stop using Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact ICU Medical Inc to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
ICU Medical Inc
Category
Health
Recall date
May 24, 2023
Units affected
Not reported
Sold at
worldwide
Recall number
FDA-Z-1565-2023
Made in
United States
Issuing agency
FDA

In context

  • ICU Medical Inc has 2 recalls in our database, including 2 rated Critical.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 903rd Health recall we've logged in 2023.
Read the official FDA notice

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