Recall Z-0407-2009 ยท GAZ Tubing, Noninvasive
Mentor Texas, Inc
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).
| Date | Dec 12, 2008 (initiated Aug 22, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.