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U.S. Department of Health and Human Services

Class 2 Device Recall Unolok

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 Class 2 Device Recall Unoloksee related information
Date Initiated by FirmNovember 06, 2015
Date PostedDecember 17, 2015
Recall Status1 Terminated 3 on May 03, 2017
Recall NumberZ-0444-2016
Recall Event ID 72616
510(K)NumberK945225 
Product Classification Needle, hypodermic, single lumen - Product Code FMI
ProductUnolok Blunt Fill Needle 18G x 1.5" Red, Sterile, Single use, Non-injectable needle, Single use, non-injection needle
Code Information Item #02463, Lot numbers: 19351R, 16561M, 17531D, 22541D, 22551D, 25551D and 25551M.
Recalling Firm/
Manufacturer		 Myco Medical Supplies Inc
158 Towerview Ct
Cary NC 27513-3595
For Additional Information ContactTim Krotchko
919-460-2535 Ext. 112
Manufacturer Reason
for Recall		Particulates: Complaints of rubber coring from the closure of injection vials.
FDA Determined
Cause 2		Under Investigation by firm
ActionMYCO 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.
Quantity in Commerce2,401,419 units (100ea/bx, 12bx/cs, 1200ea/cs)
DistributionNationwide Distribution including AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MI, NJ, NY, NV, OK, PA, TX and UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FMI
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