Recall Z-1109-2021— Becton Dickinson & Company

Name: FDA recall Z-1109-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-23

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-12-23, terminated 2022-11-21. It names one FDA 510(k) clearance: K980987. Product: BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482. Reason: The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2020-12-23
Terminated: 2022-11-21
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

BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482

Reason for recall

The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal impacts package integrity and potentially compromises sterility of the syringe.

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