ICU Medical recalls
FDA enforcement reports naming ICU Medical Inc as the recalling firm.
- Recall reports
- 17
- Class I (serious)
- 6
- Most recent report
- Mar 19, 2025
- Mar 19, 2025POTASSIUM CHLORIDE InjDrug · ICU Medical, Inc.Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEqClass I
- Mar 19, 2025POTASSIUM CHLORIDE InjDrug · ICU Medical, Inc.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 a…Class I
- Nov 23, 20220.9% Sodium Chloride Injection, USP, 100 mL flexible container bag, Rx Only, ICU Medica…Drug · ICU Medical IncLack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.Class II
- Sep 22, 2021AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers,…Drug · ICU Medical IncPresence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.Class I
- Mar 31, 20210.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured f…Drug · ICU Medical IncPresence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to useClass II
- May 27, 2020LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, IncDrug · ICU Medical IncPresence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.Class I
- Nov 13, 2019LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, IncDrug · ICU Medical IncPresence of Particulate Matter.Class I
- Nov 13, 20190.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lak…Drug · ICU Medical IncPresence of Particulate Matter.Class I
- Feb 27, 20190.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc.…Drug · ICU Medical IncCGMP DeviationsClass II
- Nov 14, 20180.9% Sodium Chloride Injection, USP Rx Only a) 250 mL NDC 0409-7983-02; b) 150 mL NDC 0…Drug · ICU Medical IncLack of Assurance of Sterility; bags have the potential to leakClass II
- 5% Dextrose Injection, USP, Rx Only, a) 25 mL NDC 0409-7923-20
- 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL…
- 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL…
- 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL…
- 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, I…
- 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc
- 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container, Hospira,…
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