Recall Z-1005-2022— ROi CPS LLC
Class II · Terminated
Class II FDA medical device recall by ROi CPS LLC, initiated 2022-03-18, terminated 2024-08-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.. Reason: 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..
- Recalling firm
- ROi CPS LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-03-18
- Terminated
- 2024-08-02
- Firm location
- Republic, MO, United States
Product description
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.