Class 2 Device Recall Ultrasound probe cover, sterile.

• Date Initiated by Firm: June 07, 2005
• Date Posted: September 21, 2005
• Recall Status: Terminated on December 17, 2007
• Recall Number: Z-1571-05
• Recall Event ID: 33313
• 510(K)Number: K050322
• Product Classification: Drape, Surgical, Antimicrobial - Product Code KKX
• Product: Ultrasound probe cover, sterile. Catalog No. 910811.
• Code Information: Lot number: 0520, expiration date: 1-10.
• FEI Number: 1526414
• 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: Customer observed unsealed packages.
• FDA Determined Cause: Other
• Action: The recalling firm called their customer and requested the customer to return un-sealed packages.
• Quantity in Commerce: 30 cases containing 10 units per case.
• Distribution: The product was distributed to one consignee: Cone Instruments, 5210 Naiman Parkway, Solon, OH 44139.
• 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 = KKX