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Terminated

Biopsy 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

FDA Recall Z-2982-2011 · Posted 2011-08-10

Recalling FirmNorth Coast Medi-Tek Inc
Recall StatusTerminated
Product CodeLOR
Date Initiated2011-05-13
Date Terminated2012-02-16
Product Quantity2,190 trays

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.

Firm Action

North 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.

Root Cause

Other

Distribution Pattern

Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K854095BIOPSY TRAY I & IINorth Coast Medi-Tek · 1985-11-25

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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