Z-3116-2017 Class II Terminated
FDA device recall Z-3116-2017 was initiated by Becton Dickinson & Company on June 13, 2017 and is designated Class II. Reason for recall: Presence of loose polypropylene foreign matter above release specification. The recall status is terminated (terminated June 22, 2020). Affected quantity: 1,249,200 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 20, 2017
- Initiation Date
- June 13, 2017
- Termination Date
- June 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,249,200 units
Product 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 for Recall
Presence of loose polypropylene foreign matter above release specification.
Distribution Pattern
US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
Code Information
Lot Numbers: 6211579, 6271695, 6154760, 6154765 & 5268868