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…
Read the official notice →- Date
- 2025-03-19
- Country
- United States
- Brand
- ICU Medical
- Product
- POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest,…
- Classification
- Class I
- Units
- Nationwide in the USA
- Category
- Drugs & medical
- Source
- FDA · Drug
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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-06-25
USICU 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…
FDA · DeviceICU Medical, Inc.Worldwide - US Nationwide distribution in the states of FL, KY, VA, MS, MA,…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
- 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 → - 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 →
Other drugs & medical recalls in the United States
- 2025-03-19
- US
Central Admixture Pharmacy Services, Inc. recalls PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy…
Presence of Particulate Matter
FDA · DrugCentral Admixture Pharmacy Services, Inc.Product was distributed nationwide within the United StatesOfficial notice → - US
Breckenridge Pharmaceutical, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- 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
Chattem Inc recalls Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured…
CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
- US
Aspen Biopharma Labs Pvt., Ltd. recalls Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for…
CGMP Deviations
FDA · DrugAspen Biopharma Labs Pvt., Ltd.Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in…Official notice → - US
CareFusion 213, LLC recalls BD ChloraPrep Clear 1mL Applicators, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Patient Preoperative Skin…
Non-Sterility: contamination of Aspergillus penicillioides, due to breach in package lidding.