Regard recall: Sterility Concern
Regard, Item Number 830067009, custom cardiovascular procedure kit
Why was Regard recalled?
ROi CPS, LLC has become aware, through a vendor issued urgent medical device recall notice, that drapes contained within select Regard customer procedure trays may have slits in the product that may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 number: 75818I; Expiration Date: 05/18/2021
- Product
- Regard, Item Number 830067009, custom cardiovascular procedure kit
- Recalling firm
- ROi CPS LLC
- Quantity
- 16 kits
- Distribution
- US Nationwide distribution in the state of Missouri.
- Recall date
- April 14, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)