WECK Visistat 35W recall: Sterility Concern
WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close…
Why was WECK Visistat 35W recalled?
Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured.
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?
Product Code: 528235, Lot numbers: 73C1600693, 73G1500681, 73H1500255, 73H1500256, 73K1500618, 73L1400006 and 73M1500130.
- Product
- WECK Visistat 35W, Disposable Skin Stapler, Rx Only, Sterile, Teleflex Medical, NC 27709. The intended use of the Visistat stapler is to close…
- Recalling firm
- Teleflex Medical
- Quantity
- 96,402 units (9,120 ea US, 87,282 ea OUS)
- Distribution
- Worldwide Distribution- U.S. (Nationwide) and countries of: Australia, Belgium, Canada, China, Germany, Hong Kong, India, Japan, Korea, Malaysia, New Zealand, Singapore and Thailand.
- Recall date
- December 21, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)