Class 3 Device Recall EZEM brand, Basic biopsy tray.

• Date Initiated by Firm: June 23, 2004
• Date Posted: September 08, 2005
• Recall Status: Terminated on February 21, 2007
• Recall Number: Z-1523-05
• Recall Event ID: 33315
• 510(K)Number: K854095
• Product Classification: General Surgery Tray - Product Code LRO
• Product: E-Z-EM brand, Basic biopsy tray, catalog no. 4125.
• Code Information: Lot number 0324 on the package. The correct lot number is 0424.
• Recalling Firm/ Manufacturer: North Coast Medi-Tek Inc; 8603 East Ave; Mentor OH 44060-4366
• For Additional Information Contact: Theresa A. Sokolowski; 440-974-0750
• Manufacturer Reason for Recall: Product contains the incorrect lot number.
• FDA Determined Cause: Other
• Action: The recalling firm sent revised correct labels, containing the correct lot number, to the consignee which were affixed to the box containing the device.
• Quantity in Commerce: 70 cases, each case containing 5 devices.
• Distribution: The product was distributed to one domestic consignee: E-Z-EM, 717 Main Street, Westbury, NY 11590.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = LRO