Reported Aug 21, 2024 · Ongoing
Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description…
ICU Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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?
- Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser. OUS units marketed
- with the following descriptionsBomba de infusi¿n Plum 360 compatible con el software ICU Medical MedNet, Plum 360 Infusion System, PLUM 360, PLUM 360" Infuser, Plum 360 Infuser compatible with ICU Medical MedNet Software, Plum 360 Infuser compatible with ICU Medical MedNet Software Refurb, Plum 360 sistema infusionale compatibile con ICU Medical MedNet Software, Pompe a perfusion Plum 360, compatible avec le logiciel ICU Medical MedNet
- Lot codes and dates
- 1
- Product Code300100413
- UDI Number (Serial Numbers)
1,154 of 1,154 codes
+M3353001004131 (4341452743414565)+M33530010041311 (43422532435113234341869743419090434292214341932343418389434180944341925743429686434297674342967743419283434295664341910243429724434297184342971043429707434296944342969243429607434295934342959243429582434295654343951543418578434186554348400843483343434838724349702343496686434976674349752943498447434968694349717443496776434973534349827143498371434963924349924243497132434991814342776843498473434969174349687143496767434966754349703843496717434983904349755943497503
- Product Code300100409
- UDI Number (Serial Numbers)
1,963 of 1,963 codes
+M33530010040916 (300074033000738730007374300072943000729230007284300072813000726330007246300072413000722230005882300116463001162230011620300116133001160530011569300115423001152530011495300114603001145730003134300106383000716730007160300071433000714130007113300071103000709730007068300069823000691330005948300040843000591730003222300054563000473330007271300072623000721230007192300071063000709130007086300070853000708130007064300070093001175430011723300116973001168430011683300116703001166330011650
- Product Code300100405
- No UDI Number (Serial Numbers
117 of 117 codes
217711622175725520001565217677432176804721757316217598512176745521763465217616621999350421775990199951612175860021759374217669642176778621767203217675162176756421767814217692222175938121764676217692692176123021766930217665142176772521759110217682652176869121766974217683302176695721767172217678832176822021759001217613821999405119994204199933932175782219993728199873832176450319986061217596422175568921759350199938522175905921759570217564681999005620005083200010442000336721756760
- Amount recalled
- 11,961 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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