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