Class 2 Device Recall

• Date Initiated by Firm: July 11, 2003
• Date Posted: October 15, 2003
• Recall Status: Terminated on April 12, 2004
• Recall Number: Z-0024-04
• Recall Event ID: 27131
• 510(K)Number: K934382 K960616
• Product Classification: Apparatus, Suction, Single Patient Use, Portable, Nonpowered - Product Code GCY
• Product: Quanta Technologies L.L.C. brand REORDER # LAPKIT 3. Contents 1 -55060 Suction/Irrigation Valve 2- 30012 Insufflation Tubing set 3- 5010 Anti Fog Solution with Sponge.; ; Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
• Code Information: los 994985, 994986 and 995044.
• Recalling Firm/ Manufacturer: Vital Concepts, Inc.; 5090 Kendrick Ct. S E; Grand Rapids MI 49512
• For Additional Information Contact: 616-954-2890
• Manufacturer Reason for Recall: The suction valve may become stuck in the 'suction on' position under vacuum.
• FDA Determined Cause: Other
• Action: A request for product return was sent to each customer beginning on July 11, 2003.
• Quantity in Commerce: 160
• Distribution: Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
• 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 = GCY and Original Applicant = VITAL CONCEPTS, INC.