medical Class II Updated 2022-05-04

ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) reg

Recalled Product

Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.

Hazard / Issue

A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

Issued by

FDA

Distribution: Nationwide (United States)

Lot/Code Info: (1) Item #830014015 - Lot number 87229O, exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P, exp. 5/31/2022; 88219P, exp 6/30/2022; 89163, exp. 6/30/2022; 89430, exp. 5/31/2022; 89926, exp. 6/30/2022; 90372, exp, 6/30/2022; 91054, exp. 12/31/2022; and 91443, exp. 5/31/2023.

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