Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CVC Tray Pediatrics. Product Code: AMS-9335CP-2. Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. Due to Vygon is conducting a voluntary recall of the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. directly.
Affected Products
CVC Tray Pediatrics. Product Code: AMS-9335CP-2.
Quantity: 300 units
Why Was This 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.
Where Was This Sold?
U.S.
About Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report