Recall Z-0736-2024— Becton Dickinson & Company

Name: FDA recall Z-0736-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-16

Class II · Ongoing

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2023-11-16. It names one FDA 510(k) clearance: K161552. Product: PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547. Reason: An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Ongoing
Initiated: 2023-11-16
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K161552 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SP SyringeBecton, Dickinson and Company·cleared 2017-02-02

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

PosiFlush Prefilled Saline Syringe with General Pump Compatibility (10mL Syringe with 10mL Saline Fill), Catalog Number 306547

Reason for recall

An incorrect stopper was used in nine lots of 10mL BD PosiFlush Normal Saline Flush Syringes with General Pump Compatibility. The use of BD PosiFlush Prefilled Flush Syringes with this stopper causes an increase in injection force, which has the potential to trigger alarms if used with a syringe pump.

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