Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Reported: May 4, 2022 Initiated: March 18, 2022 #Z-1006-2022
Product Description
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
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.
Details
- Recalling Firm
- ROi CPS LLC
- Units Affected
- 950 convenience kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Location
- Republic, MO
Frequently Asked Questions
What product was recalled? ▼
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.. Recalled by ROi CPS LLC. Units affected: 950 convenience kits.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Moderate. Recall number: Z-1006-2022.
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