Box as labeled: Regard recall
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason…
Why was Box as labeled: Regard recalled?
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
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?
UDI-DI: 60888937027053, lot# 326728.
- Product
- Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason…
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 127 boxes, 3 kits per box (381 kits total)
- Distribution
- US Nationwide distribution in the state of MO.
- Recall date
- February 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)