Unolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
FDA Recall Z-0444-2016 · Posted 2015-12-17
Recalling FirmMyco Medical Supplies Inc
Recall StatusTerminated
Product CodeFMI
Date Initiated2015-11-06
Date Terminated2017-05-03
Product Quantity2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
Reason for Recall
Particulates: Complaints of rubber coring from the closure of injection vials.
Firm Action
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/ [email protected].
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.