Device Recall Henry Schein 의 리콜

Recall

73828

Class 2

Z-1936-2016

2016-03-25

Terminated

United States

2017-04-03

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145062

Bd 10 ml syringe luer-lok tip with bd precisionglide needle 21g x 1 (0.8 mm x 25 mm) and henry schein 10 ml single use syringe luer-lock are being recalled due to possible adulteration and non-conforming manufacturing practices.

Becton Dickinson sent via email and UPS Ground an "Urgent Voluntary Product Recall" Letter dated March 25, 2016 along with a Recall Response Form and packaging instructions to their sole customer. Customers were instructed to immediately review their inventory , quarantine any affected product, and immediately discontinue shipment of the affected product. Customers should complete the Recall Response Card from and fax it to BD at 1-201-847-6990. Return all affected product with the completed Recall Response Card. If product was further distributed please identify your customers and notify them immediately of the product recall. Customers were also instructed to complete the Recall Response Form even if they do not have any affected lots in their inventory. Customers with questions were instructed to call 1-201-847-4267. For questions regarding this recall call 201-847-5612.