Biopsy Trays (CT, Puncture & Prep), Packaged individually in header bags, 10 per case. Sterile, Disposable Convenience K
FDA device recall Z-2982-2011 · posted 2011-08-10 · Terminated
Recall details
- Recalling firm
- North Coast Medi-Tek Inc
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- LOR
- Quantity affected
- 2,190 trays
- Distribution
- Nationwide Distribution CA, CO, FL, GA, ID, IL, MA, NC, NE, NY, OH, OK, PA, TN, NC and TX
- Date initiated
- 2011-05-13
- Date posted
- 2011-08-10
- Date terminated
- 2012-02-16
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BIOPSY TRAY I & II (K854095) | North Coast Medi-Tek | 1985-11-25 |