Reported Feb 28, 2018 · Terminated
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
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?
- 20Ga x .75 LifeGuard Huber Needle with Y-site
- Product CodeCLGY-2034
- Lot codes and dates
- Lot Number1706017D
- Amount recalled
- 396 units
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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