Class 2 Device Recall

• Date Initiated by Firm: November 07, 2003
• Date Posted: July 20, 2004
• Recall Status: Terminated on September 13, 2004
• Recall Number: Z-0260-04
• Recall Event ID: 27694
• 510(K)Number: K934382
• Product Classification: Tube, Aspirating, Flexible, Connecting - Product Code BYY
• Product: Reorder # Lapkit 3. Contents: 1- 55060 suction/irrigation valve 2- 30012 insufflation tubing set 3- 5010 anti fog solution with sponge. Sterile. single use. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
• Code Information: lot 994986.
• FEI Number: 1000115375
• Recalling Firm/ Manufacturer: Vital Concepts, Inc.; 5090 Kendrick Ct Se; Grand Rapids MI 49512-9649
• For Additional Information Contact: 616-954-2890
• Manufacturer Reason for Recall: The probe may separate from the cannula.
• FDA Determined Cause: Other
• Action: Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field.
• Quantity in Commerce: 70
• Distribution: Arizona, Illinois, Indiana, Michigan and Pennsylvania.
• 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 = BYY