Recall Z-2982-2011 ยท LOR
North Coast Medi-Tek Inc
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
| Date | Aug 10, 2011 (initiated May 13, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| 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. |
| Quantity | 2,190 trays |
| Distribution | Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854095 | BIOPSY TRAY I & II North Coast Medi-Tek, Nov 25, 1985 |