Icu Medical

18 FDA enforcement records linked to this company.

• recall — Class I2025-03-19

  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 affixed to the product flexible container.

• recall — Class I2025-03-19

  Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq

• recall — Class II2022-11-23

  Lack of assurance of sterility: Bags have the potential to leak in the flexible containers which may compromise sterility.

• recall — Class I2021-09-22

  Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.

• recall — Class II2021-03-31

  Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

• recall — Class I2020-05-27

  Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.

• recall — Class I2019-11-13

  Presence of Particulate Matter.

• recall — Class I2019-11-13

  Presence of Particulate Matter.

• recall — Class II2019-02-27

  CGMP Deviations

• recall — Class II2018-11-14

  Lack of Assurance of Sterility; bags have the potential to leak

• recall — Class II2018-11-14

  Lack of Assurance of Sterility; bags have the potential to leak

• recall — Class II2018-06-27

  Lack of assurance of sterility: Bags have potential to leak.

• recall — Class II2018-06-27

  Lack of assurance of sterility: Bags have potential to leak.

• recall — Class II2018-06-27

  Lack of assurance of sterility: Bags have potential to leak.

• recall — Class II2018-06-27

  Lack of assurance of sterility: Bags have potential to leak.