Recall Z-1055-2015 ยท FMF Syringe, Piston
Becton Dickinson & Company
BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40 mm), not for skin injection; Catalog #305064 BD 10 mL Syringe Luer-Lok Tip with BD Precision Glide Needle 20G x 1 (0.9mm x 25mm); Catalog #305064 Product Usage: 1) BD Blunt Plastic Cannula is used to penetrate pre-
| Date | Feb 5, 2015 (initiated Dec 19, 2014) |
| Status | Terminated |
| Reason | The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe. |
| Root cause | Device Design |
| Action | BD sent an Urgent Product Advisory Notice letter dated 12/19/2014. The letter identified the affected product, problem and actions to be taken. Customers are advised of the issue with the product and should notify their customers. The attached Product Advisory Response Form should be completed and faxed to 1-866-551-2707. Questions can be directed to 1-866-367-4703. |
| Quantity | 564,000 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |