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U.S. Department of Health and Human Services

Class 2 Device Recall Novy cornual cannulation set

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  Class 2 Device Recall Novy cornual cannulation set see related information
Date Initiated by Firm January 08, 2010
Date Posted March 15, 2010
Recall Status1 Terminated 3 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/
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 2
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