Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
This recall has been terminated (originally issued December 17, 2015).
- Company
- Myco Medical Supplies Inc
- Recall Initiated
- November 6, 2015
- Posted
- December 17, 2015
- Terminated
- May 3, 2017
- Recall Number
- Z-0444-2016
- Quantity
- 2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
- Firm Location
- Cary, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Particulates: Complaints of rubber coring from the closure of injection vials.
Distribution
Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Lot / Code Info
Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.
Root Cause
Under Investigation by firm
Action Taken
MYCO Medical sent an Advisory Notice dated November 6, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory, if any affected product found MYCO request that the customer return the product to MYCO Medical following the instructions provided on the Materials for Return Form. Customers with questions were instructed to call Customers Service at 919-460-2535/ customerservice&mycomedical.com or cal the Quality Department at 919-460-2535/ QA@mycomedical.com.