Mentor Aseptic Transfer Set, Cat. #350-8400 (contains BD 60mL Luer-Lok Syringe). Aseptic transfer set manufactured by Mentor Texas, LP, Irving, TX 75038 (BD 60 mL Luer-Lok syringe manufactured by Becton Dickinson, Franklin Lakes, NJ 07417).
FDA Recall Z-0407-2009 · Posted 2008-12-12
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Recalling FirmMentor Texas, Inc
Recall StatusTerminated
Product CodeGAZ
Date Initiated2008-08-22
Date Terminated2010-08-26
Product Quantity32,480 Aseptic Transfer Sets (4 syringes/set)
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.
Firm Action
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
Distribution Pattern
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 South Africa.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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