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U.S. Department of Health and Human Services

Class 2 Device Recall North Coast MediTek Inc Biopsy Trays

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 Class 2 Device Recall North Coast MediTek Inc Biopsy Trayssee related information
Date Initiated by FirmMay 13, 2011
Date PostedAugust 10, 2011
Recall Status1 Terminated 3 on February 16, 2012
Recall NumberZ-2982-2011
Recall Event ID 59386
510(K)NumberK854095 
Product Classification General surgery tray - Product Code LOR
ProductBiopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience Kits used for diagnostic radiology procedures. A diagnostic radiology kit used in CT and general biopsies
Code Information Model #'s: 255566, 260945, XP-2033, 266970, XP-1800R1, 254112 & NC-4072, Lot #1114 Exp. 10/13
Recalling Firm/
Manufacturer		 North Coast Medi-Tek Inc
8603 East Ave
Mentor OH 44060-4366
For Additional Information Contact
440-974-0750
Manufacturer Reason
for Recall		During routine bioburden testing, unusually high results were found for a Bioburden Test done on 4/19/11. Bioburden Level reported as >150,000 CFU. Our Alert Level is 17,000 CFU and the Action Level is 23,000 CFU.
FDA Determined
Cause 2		Other
ActionNorth Coast Medi - Tek Inc. sent a URGENT PRODUCT RECALL letter dated May 13, 2011 to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The customers were instructed to stop shipment of all remaining product and return to recalling firm. They were also requested to contact their customers and notify them of the recall and retieve all remaining product. For further questions please call (440) 974-0750.
Quantity in Commerce2,190 trays
DistributionNationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX
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 = LOR
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