Reported Aug 30, 2023 · Ongoing
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451,…
ICU Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical Inc · 600 N Field Dr · Lake Forest, IL · 60045-4835
Is this the product you have?
- Plum 360 Infusion System
- List Numbers
300100405300100409300100413300100414300100415300100418300100451300100452300100453300100481300100483300100613300101013300101113300101114300101313300101379300102213300102713300102913300103413300103414300104213300105413300105713300106313300106513300106581300107813300107814300108513300108813300108814300109913infusion pump
- Lot codes and dates
- UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021
- Amount recalled
- 93135 devices
Why it was recalled
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
This product could cause temporary or reversible health problems — stop using it.
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