Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0680-2018 — CVC Tray Pediatrics. Product Code: AMS-9335CP-2.

U.S. FDA — Device Enforcement · United States · 2017-07-24 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0680-2018
Date of alert
2017-07-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.