ICU Medical, Inc. recalls Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List…
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are…
Read the official notice →- Date
- 2024-11-27
- Country
- United States
- Brand
- ICU Medical
- Product
- Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List…
- Classification
- Class I
- Units
- Worldwide distribution: US (nationwide) including Puerto Rico and OUS…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More ICU Medical recalls
- 2025-03-19
USICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045,…
Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
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ICU Medical, Inc. recalls POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling…
- 2024-12-18
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ICU Medical, Inc. recalls ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer Device prevents the transfer of environmental contaminants. The…
Due to finished goods incorrectly packaged and labeled.
FDA · DeviceICU Medical, Inc.Worldwide - U.S. Nationwide distribution in the state of IL and the country of…Official notice → - 2024-08-21
- US
ICU Medical Inc recalls Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971,…
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…
FDA · DeviceICU Medical IncWorldwide Distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2023-08-30
- US
ICU Medical Inc recalls Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453,…
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.
- 2023-05-24
- US
ICU Medical Inc recalls Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010
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…
Other drugs & medical recalls in the United States
- 2024-11-27
- US
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Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
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Maquet Cardiovascular, LLC recalls Acrobat-i Vacuum Stabilizer System. Model Number C-OM-10000Z
Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Albania, Algeria,…Official notice → - US
Novosource, LLC recalls NovoHip Biolox Ball Head 32mmL Ref: 1345-2803 NovoHip Total Hip System - NovoHip Total Hip System is a non-cemented hip prosthesis that…
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Caire, Inc. recalls CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.
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