Recall Z-1577-2013
Becton Dickinson & Company · initiated May 1, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
BD SafetyGlide Allergy. REF 305950 Sterile Allergy Treatment Syringe Tray. The device is used for aspiration and injection of medications.
Codes / lots: Catalog/Lot Number: REF#305950 Lot 2132028 and Lot 2159189
Reason for recall
There has been an increase in complaints regarding the needle/safety mechanism disengaging from the syringe.
FDA-determined cause: Process control
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.
Details
- Recall number
- Z-1577-2013
- Initiated
- May 1, 2013
- Posted by FDA
- June 21, 2013
- Terminated
- September 25, 2013
- Product code
- MEG – Syringe, Antistick
- Quantity
- 1,326,000 units
- Distribution
- Worldwide Distribution including US Nationwide and the countries of Canada and Suriname.
- Recalling firm
- Becton Dickinson & Company, Franklin Lakes, NJ