Case Carton: BD Oral Dispensing Syringe 1 mL Clear with Tip Cap BD, Franklin Lakes, NJ 07417 USA Made in USA www.bd.com
FDA device recall Z-0564-2013 · posted 2012-12-19 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD received a complaint report for mixed syringe tips (oral and non-oral syringe tips) within the same lot.
- Action taken
- Becton Dickinson sent a Urgent Product Recall letter/Customer Packing list dated October 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to review inventory and determine if they have any of the affected product. If so, it should be removed from inventory. The enclosed customer list should be completed as well. Any questions please call 1-201-847-4267.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FMF
- Quantity affected
- 2,786,000 units
- Distribution
- (USA) nationwide
- Date initiated
- 2012-10-02
- Date posted
- 2012-12-19
- Date terminated
- 2016-05-03
- 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 (K980987) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998-06-11 |