Recall Z-2673-2014— Becton Dickinson & Company

Name: FDA recall Z-2673-2014
Creator: U.S. Food and Drug Administration
Published: 2014-07-22

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2014-07-22, terminated 2015-04-21. It names one FDA 510(k) clearance: K121050. 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.. Reason: BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553)..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2014-07-22
Terminated: 2015-04-21
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K121050 — 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGEBecton, Dickinson & CO·cleared 2013-02-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

BD received some reports of open seals found on the BD Posiflush SF Flush Syringe 10 mL (Ref #306553).

Data sourced from openFDA. This site is unofficial and independent of the FDA.