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U.S. Department of Health and Human Services

Class 2 Device Recall Mentor Aseptic Transfer Set

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  Class 2 Device Recall Mentor Aseptic Transfer Set see related information
Date Initiated by Firm August 22, 2008
Date Posted December 12, 2008
Recall Status1 Terminated 3 on August 26, 2010
Recall Number Z-0407-2009
Recall Event ID 49522
Product Classification Aseptic Transfer Set - Product Code GAZ
Product 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).
Code Information Aseptic Transfer Sets: All lots.  Syringes: Reorder Number: 309653; Lot numbers beginning with the numbers 5, 6, or 7 and also the following lot numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154, 8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401, 8072409, 8072414, 8072419, 8079645, and 8079656.
Recalling Firm/
Manufacturer		 Mentor Texas, Inc
3041 Skyway Cir N
Irving TX 75038-3500
For Additional Information Contact Steven Jackson
972-252-6060
Manufacturer 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.
FDA Determined
Cause 2		 Package design/selection
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.
Quantity in Commerce 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 South Africa.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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