3-Way Standardbore Stopcock recall: Sterility Concern
3-Way Standardbore Stopcock. Product Code: AMS-100.
Why was 3-Way Standardbore Stopcock recalled?
Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging. This potential lack of adhesive may affect the sterility of the product.
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?
Lot Number: 1706064D
- Product
- 3-Way Standardbore Stopcock. Product Code: AMS-100.
- Recalling firm
- Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
- Quantity
- 200 units
- Distribution
- U.S.
- Recall date
- February 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)