regard recall: Sterility Concern
regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
Why was regard recalled?
A nonsterile component was packaged in a sterile convenience kit.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #91423, Exp. 02/08/2024, UDI (01)10194717101949(17)240208(10)91423.
- Product
- regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.
- Recalling firm
- ROi CPS LLC
- Quantity
- 180 kits
- Distribution
- US Nationwide distribution in the state of FL.
- Recall date
- July 6, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)