FDA recall Z-0682-2018

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. · Class II · device

Product

3-Way Standardbore Stopcock. Product Code: AMS-100.

Reason for recall

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.

Distribution

U.S.

Key facts

Status: Terminated
Initiation date: 2017-07-24
Report date: 2018-02-28
Termination date: 2019-11-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Dover, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0682-2018