BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injecti
FDA device recall Z-1577-2013 · posted 2013-06-21 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MEG
- Quantity affected
- 1,326,000 units
- Distribution
- Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.
- Date initiated
- 2013-05-01
- Date posted
- 2013-06-21
- Date terminated
- 2013-09-25
- Location
- Franklin Lakes, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BECTON DICKINSON SYRINGE (K992734) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1999-10-01 |