Z-0444-2016 Class II Terminated
FDA device recall Z-0444-2016 was initiated by Myco Medical Supplies Inc on November 6, 2015 and is designated Class II. Reason for recall: Particulates: Complaints of rubber coring from the closure of injection vials. The recall status is terminated (terminated May 3, 2017). Affected quantity: 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs).
Recall Details
- Product Type
- Devices
- Report Date
- December 23, 2015
- Initiation Date
- November 6, 2015
- Termination Date
- May 3, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
Product Description
Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Reason for Recall
Particulates: Complaints of rubber coring from the closure of injection vials.
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Code Information
Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.