Recall Z-2007-2019— Becton Dickinson & Company

Name: FDA recall Z-2007-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-01

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-02-01, terminated 2020-06-11. It names one FDA 510(k) clearance: K980987. Product: 3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573. Reason: The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-02-01
Terminated: 2020-06-11
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K980987 — BECTON DICKINSON SYRINGEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1998-06-11

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

3mL Luer-Lok Syringe, Catalog Number 309657, UDI 30382903096573

Reason for recall

The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

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