Recall Z-0252-2020— Becton Dickinson & Company

Name: FDA recall Z-0252-2020
Creator: U.S. Food and Drug Administration
Published: 2019-03-07

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-03-07, terminated 2022-02-11. It names one FDA 510(k) clearance: K982541. Product: BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608. Reason: BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2019-03-07
Terminated: 2022-02-11
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K982541 — VACUTAINER BRAND ECLIPSE BLOOD COLLECTION NEEDLE, MODELS# 368607 & 368608Becton Dickinson Vacutainer Systems·cleared 1998-10-28

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 Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

Reason for recall

BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

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