Reported Feb 28, 2018 · Terminated

Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

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

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · 87 Venture Dr · Dover, NH · 03820-5914

Is this the product you have?

  • Nutrisafe 2 35 mL Syringe for Safety Connection
  • Product Code1015.352M
Lot codes and dates
  • Lot Number1705060D
Amount recalled
N/A

This recall covers 5 products

The agency filed one notice per product. You are reading one of them; the other 4 are below.

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 7, 2019 · Data as of Sep 19, 4:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.