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Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 3-Way Standardbore Stopcock. Product Code: AMS-100.
Recalled February 28, 2018 · FDA recall Z-0682-2018 · Vygon MFG, Inc., dba/ Churchill Medical Systems
Hazard
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. · FDA Class II
Units
200 units
Sold at
U.S.
Description
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.
Product
3-Way Standardbore Stopcock. Product Code: AMS-100.
Manufacturer(s)
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →