Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Me

FDA device recall Z-0407-2009 · posted 2008-12-12 · Terminated

Recall details

Recalling firm

Mentor Texas, Inc

Reason for recall

The Mentor Aseptic Transfer Set contains a component, the BD 60mL Luer-Lok Syringe, which is under recall by Becton Dickinson due to a package integrity issue.

Action taken

Firm sent notification, along with a copy of the Becton Dickinson recall letter, to consignees on 08/18/08. Consignees asked to inspect inventory of Mentor Aseptic Transfer Sets for affected BD 60mL syringes and to complete and return the included Device Accountability Worksheet. For additional information, please contact Mentor Customer Service at 800-235-5731.

Root cause

Package design/selection

Status

Terminated

Product code

GAZ

Quantity affected

32,480 Aseptic Transfer Sets (4 syringes/set)

Distribution

Worldwide Distribution; product sent to all states (except Alaska), Washington DC and Puerto Rico. Product also sent to the following countries: Australia, Canada, Costa Rica, Korea, New Zealand and S

Date initiated

2008-08-22

Date posted

2008-12-12

Date terminated

2010-08-26

Location

Irving, TX