Recall Z-2889-2020— Becton Dickinson & Company

Name: FDA recall Z-2889-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-28

Class II · Terminated

Class II FDA medical device recall by Becton Dickinson & Company, initiated 2020-07-28, terminated 2021-04-23. It names one FDA 510(k) clearance: K951254. Product: BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack. Reason: Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different degrees, resulting in missing and/or partially printed scale numbers and scale lines..

Recalling firm: Becton Dickinson & Company
Classification: Class II
Status: Terminated
Initiated: 2020-07-28
Terminated: 2021-04-23
Firm location: Franklin Lakes, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K951254 — SAFETYGLIDE NEEDLEBd Becton Dickinson Vacutainer Systems Preanalytic·cleared 1995-10-07

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 SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack

Reason for recall

Printed scale markings on the 3mL SafetyGlide syringes, with catalog # 305924, Lot# 8289599, are printed incorrectly. The scale is skewed to different 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.