FDA Enforcement
Class II
Terminated
BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
Recall: Z-2748-2017
·
Reported July 26, 2017
Enforcement
- Recall Number
- Z-2748-2017
- 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 SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below the surface of the skin, injection into intravenous ports and tubings external to the patient. The needlestick prevention feature of the device contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards against accidental needle sticks during normal handling and disposal of the used needle/syringe combination
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
6022838 2021-01
Distribution
Nationwide Distribution
Quantity
29,500 units