Recall Z-2065-2020— Becton Dickinson & Company

Name: FDA recall Z-2065-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-16

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-04-16, terminated 2021-09-01. It names one FDA 510(k) clearance: K153481. Product: BD Posiflush SF Saline Flush Syringe (US Distributed Catalog 306553), UDI 50382903065535. Reason: This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2020-04-16
Terminated: 2021-09-01
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K153481 — 0.9% Sodium Chloride Injection, USP BD PosiFlush SF SyringeBecton, Dickinson and Company·cleared 2016-04-04

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 (US Distributed Catalog 306553), UDI 50382903065535

Reason for recall

This product has been confirmed to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

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