ICU Medical, Inc. recalls ICU Medical Plum Solos, Item number 400011001; infusion pump
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager…
Read the official notice →- Date
- 2025-06-25
- Country
- United States
- Brand
- ICU Medical
- Product
- ICU Medical Plum Solos, Item number 400011001; infusion pump
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-09-10
US
ICU Medical Inc. recalls Smiths Medical CADD Medication Cassette Reservoir with clamp and female Luer. Nonvented stopper included. 50mL, Product Code 21-7001-24
Certain CADD 50 mL and 100 mL Medication Cassette Reservoirs may exhibit weakened medication bag welds along the bag perimeter inside the plastic housing. This could result in medication leakage along the bag perimeter.
- 2025-08-13
US
ICU Medical, Inc. recalls Plum Duo Infusion System, List Number: 400020401
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- 2025-07-23
US
ICU Medical, Inc. recalls SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000
Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution including in the states of TX, SD, ID,…Official notice →- 2025-05-21
US
ICU Medical, Inc. recalls LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2
Firm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate change values with certain limits, potentially resulting in over-delivery…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of CA, FL, IA, KY, LA,…Official notice →- 2025-03-19
US
ICU 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
US
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…
Other drugs & medical recalls in the United States
- 2025-06-26
US
Boyro Baby Walkers Recalled Due to Risk of Serious Injury or Death to Children from Fall Hazard; Violations of the Federal Standard for Infant Walkers and Lead Content…
The recalled baby walkers violate the federal safety standard for infant walkers because they can fit through a standard doorway and fail to stop at the edge of a step as required, posing a risk of serious injury or…
- 2025-06-25
US
Diagnostica Stago, Inc. recalls STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and…
Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
FDA · DeviceDiagnostica Stago, Inc.The affected lot was distributed to customers in various US states in October…Official notice →US
Fresenius Medical Care Holdings, Inc. recalls 5008X HDF Hemodialysis Blood Tubing Set, 24 units per case, with the following models: a. 5008X Standard HDF Bloodline,…
Potential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD), hemofiltration (HF), and isolated ultrafiltration.
FDA · DeviceFresenius Medical Care Holdings, Inc.US Nationwide distribution in the state of Massachusetts.Official notice →US
BALT USA, LLC recalls Prestige Coil System REFs/UDI-DI codes: PRES0153CXPPLT 00810068567311 PRES1045CPKPLT 00810068567663 PRES1245CPKPLT 00810068567694…
Due to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification.
FDA · DeviceBALT USA, LLCWorldwide - U.S. Nationwide distribution including in the states of AL, AR,…Official notice →US
Preat Corp recalls Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with…
Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant.
FDA · DevicePreat CorpU.S. Nationwide distribution in the states of AZ, CA, GA, MO, NJ, NY, OH, PA,…Official notice →US
Chamberlain Technologies LLC recalls SURGIMESH WN, Polymeric Surgical Mesh, 14cm x 15cm Flat Sheet, Model/Catalog Number: T1415
Potential presence of residual adhesive material on the mesh surface.
FDA · DeviceChamberlain Technologies LLCUS distribution to states of: Illinois, Nebraska, & CaliforniaOfficial notice →