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FDAJuly 24, 2017device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

vygon mfg inc dba churchill medical systemsvygonvygon mfg

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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3-Way Standardbore Stopcock. Product Code: AMS-100. — Recall Details · AllClear