FDA Enforcement
Class II
Terminated
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) 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 needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging
Recall: Z-3116-2017
·
Reported September 20, 2017
Enforcement
- Recall Number
- Z-3116-2017
- Event ID
- 77650
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Becton Dickinson & Company
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 20, 2017
- Initiation Date
- June 13, 2017
- Classification Date
- September 11, 2017
- Termination Date
- June 22, 2020
- Address
- 1 Becton Dr, N/A, Franklin Lakes, NJ, 07417-1815, United States
Description
BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) 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 needle stick prevention feature of the device contains a mechanism that covers the needlepoint after use. Bulk Non Sterile configuration is intended for further manufacturing, processing or repackaging
Reason
Presence of loose polypropylene foreign matter above release specification.
Code Info
Lot Numbers: 6211579, 6271695, 6154760, 6154765 & 5268868
Distribution
US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
Quantity
1,249,200 units