Class 2 Device Recall Flexipet Denuding pipette 130 micron

• Date Initiated by Firm: March 02, 2008
• Date Posted: September 18, 2008
• Recall Status: Terminated on September 18, 2008
• Recall Number: Z-2176-2008
• Recall Event ID: 48629
• 510(K)Number: K983596
• Product Classification: Pipette - Product Code MQH
• Product: Flexipet Denuding pipette 130 micron. The product is boxed with 5 vials of 10. The device is used for the intracytoplasmic single sperm injection of oocytes.
• Code Information: Lot number N74091
• Recalling Firm/ Manufacturer: Cook Vascular Inc.; 1186 Montgomery Ln; Vandergrift PA 15690-6065
• For Additional Information Contact: Thomas Kardos; 724-845-8621
• Manufacturer Reason for Recall: mislabeled - 300 micron flexipets labeled as 130 micron and vice versa
• FDA Determined Cause: Employee error
• Action: The recalling firm issued an Urgent product Recall letter on 3/3/08. The letter informed the customers of the problem and that the pouch is correctly labeled. Customers were instructed to return product and notify any sub accounts. Please contact Cook Vascular at 1-724-845-8621 for assistance.
• Quantity in Commerce: 100 boxes
• Distribution: The product was shipped to physicians in CA, FL, GA, IN, NJ, NM, NV, WA , and WI.
• 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 = MQH