Class 2 Device Recall Novy cornual cannulation set

• Date Initiated by Firm: January 08, 2010
• Date Posted: March 15, 2010
• Recall Status: Terminated on December 10, 2010
• Recall Number: Z-1137-2010
• Recall Event ID: 54231
• 510(K)Number: K931476
• Product Classification: Gynocological catheter - Product Code MOV
• Product: Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.
• Code Information: U1707021, U1716443, U1718282, U1718283, U1721655, U1739397, U1752842, U1755314, U1755769, U1834419, U1834420, U1834421, UF1748711, UF1758368, and UF1758369.
• Recalling Firm/ Manufacturer: Cook Women'S Health; 1100 W Morgan St; Spencer IN 47460-9426
• For Additional Information Contact: Julie Cooper; 812-829-4891 Ext. 7241
• Manufacturer Reason for Recall: The distal tip may separate from the catheter while the catheter is in the patient.
• FDA Determined Cause: Process control
• Action: Cook Women's Health sent Urgent Recall Notice letters dated 1/8/2010. Consignees were instructed to return product to the manufacturer for credit.
• Quantity in Commerce: 721 both products
• Distribution: USA, Ireland, China, Canada, India, Australia, Hong Kong.
• 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 = MOV and Original Applicant = COOK OB/GYN