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…
Read the official notice →- Date
- 2024-08-21
- Country
- United States
- Brand
- ICU Medical
- Product
- Replacement Battery List Number SUB0000594 and SUB0000864 found in Plum A+ & Plum A+3 Infusion Systems, Pump List Numbers: 11005, 11971,…
- Classification
- Class I
- Units
- Worldwide Distribution: US (nationwide) and OUS (foreign) countries of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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., 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
- US
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 → - 2024-11-27
- US
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…
FDA · DeviceICU Medical, Inc.Worldwide distribution: US (nationwide) including Puerto Rico and OUS…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…
- 2022-11-23
- US
ICU Medical Inc recalls 0.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC…
Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.
Other drugs & medical recalls in the United States
- 2024-08-21
- US
Beckman Coulter, Inc. recalls Discrete photometric chemistry analyzer for clinical use.
Beckman Coulter, Inc. has identified a rise in reagent carousel motion errors in Access 2 Immunoassay System Analyzers that appear to be caused by misaligned index wheels housed within the reagent carousel module.…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of NE, MT, LA, TX, NY,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, Catalog #C11137.
The reason for this recall is Beckman Coulter has determined that when a DxI 9000 Access Immunoassay Analyzer is connected to a Laboratory Automation System (LAS); is running with the software versions 1.17 and below;…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, FL,…Official notice → - US
Defibtech, LLC recalls RMU-2000 Automated Chest Compression Device
Problem in the device's motor may cause the device to stop compressions. This may lead to a delay in therapy if the device fails to operate, and could lead to patient injury or death.
FDA · DeviceDefibtech, LLCDomestic distribution to CT, FL, NJ, SC, TN. Foreign distribution to JapanOfficial notice → - US
Palodex Group Oy recalls Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray…
It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within…
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Taro Pharmaceuticals U.S.A., Inc. recalls Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton,…
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Defective container; yellow colored spike from cap lodged in the nozzle