Recall Z-1577-2013 ยท MEG Syringe, Antistick
Becton Dickinson & Company
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
| Date | Jun 21, 2013 (initiated May 1, 2013) |
| Status | Terminated |
| Reason | There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe. |
| Root cause | Process control |
| Action | Direct consignees were contacted by phone and email on 05/01/2013 and instructed to return the affected product. End users were mailed "Urgent: Product Recall" letters/Response Forms dated 05/01/2013. The notice advises customers of the product issue, identifies affected product and provides instructions on how to handle affected product. |
| Quantity | 1,326,000 units |
| Distribution | Worldwide Distribution including US Nationwide and the countries of Canada and Suriname. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992734 | BECTON DICKINSON SYRINGE Bd Becton Dickinson Vacutainer Systems Preanalytic, Oct 1, 1999 |