FDA-Device2018-02-28Class II

19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

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

Sold states
U.S.
Affected count
156
Manufactured in
87 Venture Dr, N/A, Dover, NH, United States
Products
19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0681-2018

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