Device product
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
Z-3116-2017
Product summary
- Event
- Event 77650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,249,200 units
- Official record key
device-enforcement:Z-3116-2017
Official wording
Reason: Presence of loose polypropylene foreign matter above release specification.
Code information: Lot Numbers: 6211579, 6271695, 6154760, 6154765 & 5268868
Distribution pattern: US Distribution to: TX, PA, VA, CA, NY, IL, MI, NC, SC and KS.
Derived failure modes
-
Foreign material or chemical contamination
foreign matter