BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe
FDA device recall Z-1055-2015 · posted 2015-02-05 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- The stopper of the 10mL BD Luer-Lok syringe is not properly seated in the syringe.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 564,000 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2014-12-19
- Date posted
- 2015-02-05
- Date terminated
- 2015-12-07
- 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 |
|---|---|---|
| BD SINGLE USE, HYPODERMIC SYRINGE (K110771) | Becton, Dickinson and Company | 2011-05-13 |
| BECTON DICKINSON BLUNT PLASTIC CANNULA (K974363) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-03 |
| BECTON DICKINSON BLUNT STEEL CANNULA (K944931) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-08-29 |