Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. recall: Sterility Concern
Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
Why was Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. recalled?
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
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?
Batch No. 50498479; 50526605; 50527117; 50553176; 50579348; 50581344; 50588245; 50590542; 50591919; 50592295 & 50603355
- Product
- Smith & Nephew Whipknot Soft Tissue Cinch #5 Sutures. PN: 7211015
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 22
- Distribution
- Distributed to accounts in 7 states: AZ, ME, NY, OH, PA, TN, and VT; and PR.
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)