Recalls / —
—#129409
Product
BD PosiFlush SF Saline Flush Syringe 0.9 Sodium Chloride Injection, USP 10 mL REF 306553. Intended to be used only for the flushing of indwelling vascular access devices.10 mL BD PosiFlush Normal Saline Flush Syringes are generally compatible for use with syringe pumps.
- FDA product code
- NGT — Saline, Vascular Access Flush
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K121050
- Affected lot / code info
- REF #306553 Lot numbers 3024261 - exp 12-2015 3046276 - exp 01-2016 4128353 - exp 04-2017
Why it was recalled
BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
Root cause (FDA determination)
Packaging
Action the firm took
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.
Recalling firm
- Firm
- Becton Dickinson & Company
- Address
- 1 Becton Dr, Franklin Lakes, New Jersey 07417-1815
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2014-07-22
- Posted by FDA
- 2014-09-22
- Terminated
- 2015-04-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #129409. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.