Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls 3-Way Standardbore Stopcock. Product Code: AMS-100.

Recall date

July 24, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0682-2018

FDA classification

Class II

Brand / firm

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Sold / distributed

U.S.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

3-Way Standardbore Stopcock. Product Code: AMS-100.