FDA Enforcement Class II Terminated

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

Recall: Z-2889-2020 · Reported September 2, 2020

Enforcement

Recall Number
Z-2889-2020
Event ID
86120
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Becton Dickinson & Company
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
September 2, 2020
Initiation Date
July 28, 2020
Classification Date
August 26, 2020
Termination Date
April 23, 2021
Address
1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States

Description

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.

Code Info

Catalog #: 305924 Lot #: 8289599 UDI #: 30382903059240

Distribution

US and Canada

Quantity

125,200 units