Device product
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Z-0444-2016
Product summary
- Event
- Event 72616
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
- Official record key
device-enforcement:Z-0444-2016
Official wording
Reason: Particulates: Complaints of rubber coring from the closure of injection vials.
Code information: Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.
Distribution pattern: Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Derived failure modes
-
Foreign material or chemical contamination
Particulates