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 Recall Z-2673-2014 · Posted 2014-09-22
Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeNGT
Date Initiated2014-07-22
Date Terminated2015-04-21
Product Quantity3,088,320 units
Reason for Recall
BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).
Firm Action
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
Distribution Pattern
Nationwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.