Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion Systems, List Numbers: a) 11005, b) 1197
Summary
The FDA issued a Class I for Replacement Battery List Number SUB0000594 found in Plum A+ & Plum A+3 Infusion by ICU Medical Inc. Reason: Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than ex.
Details
Source
Device Recall
External ID
Z-1566-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
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) 20678, f) 20679, g) 20792, h) 60629, i) 12348, j) 11973
Lot/Code Info: All devices containing CSB BATTERY displaying the first two (2) characters as 22 or lower
Quantity Affected: 23815 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.
Distribution
worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-22
Company
Lake Forest, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 147 device recalls issued in the same week, part of 413 device-related FDA actions this month.
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ICU Medical Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ICU Medical Inc have FDA actions?
ICU Medical Inc has 95 FDA actions in our database, including 85 recalls and 10 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1566-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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