Class 3 Device Recall SourceOne Healthcare TechnoUltrasound trays.

• Date Initiated by Firm: January 18, 2005
• Date Posted: September 21, 2005
• Recall Status: Terminated on February 21, 2007
• Recall Number: Z-1572-05
• Recall Event ID: 33314
• 510(K)Number: K854095
• Product Classification: General Surgery Tray - Product Code LRO
• Product: SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
• Code Information: Lot number 0503, expiration date 11-07.
• 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: Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
• FDA Determined Cause: Other
• Action: The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.
• Quantity in Commerce: 5 cases, each case containing 10 kits (50 total kits).
• Distribution: The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.
• 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