Surgical Suture Kit recall: Sterility Concern
Surgical Suture Kit
Why was Surgical Suture Kit recalled?
There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.
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?
Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717
- Product
- Surgical Suture Kit
- Recalling firm
- Stradis Healthcare
- Quantity
- 7340 units
- Distribution
- US Distribution to NC.
- Recall date
- June 1, 2022
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)