Recall Z-0500-2020— Becton Dickinson & Company

Name: FDA recall Z-0500-2020
Creator: U.S. Food and Drug Administration
Published: 2019-10-14

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-10-14, terminated 2020-10-16. It names one FDA 510(k) clearance: K161552. Product: BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only). Reason: Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-10-14
Terminated: 2020-10-16
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

BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)

Reason for recall

Limited number of syringes labeled Posiflush Experimental Product and Not for Human Use being mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes.

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