FDA Enforcement
Class II
Terminated
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Recall: Z-2747-2017
·
Reported July 26, 2017
Enforcement
- Recall Number
- Z-2747-2017
- Event ID
- 77513
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 26, 2017
- Initiation Date
- September 16, 2016
- Classification Date
- July 19, 2017
- Termination Date
- March 20, 2018
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
Description
BD 5ml Syringe Luer-Lok" Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 40mm) Catalog #305062
Reason
BD identified that several lots did not receive the specified dose of irradiation necessary to meet the Sterility Assurance Level (SAL) required.
Code Info
6204878 2021-07
Distribution
Nationwide Distribution
Quantity
22,400 units