BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for t
FDA device recall Z-2673-2014 · posted 2014-09-22 · Terminated
Recall details
- Recalling firm
- Becton Dickinson & Company
- Reason for recall
- BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
- Action taken
- BD sent recall letters/recall response cards dated 7/22/2014 via e-mail or UPS 2nd day mail. Customers are asked to examine their inventory and quarantine any affected product subject to recall. Customers should complete the Recall Response Card and fax it back to BD at 1-201-847-6990. Any questions can be directed to 1-888-237-2762 option 3.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- NGT
- Quantity affected
- 3,088,320 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2014-07-22
- Date posted
- 2014-09-22
- Date terminated
- 2015-04-21
- 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 |
|---|---|---|
| 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE (K121050) | Becton, Dickinson & CO | 2013-02-07 |