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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 setsee related information
Date Initiated by FirmJanuary 08, 2010
Date PostedMarch 15, 2010
Recall Status1 Terminated 3 on December 10, 2010
Recall NumberZ-1137-2010
Recall Event ID 54231
510(K)NumberK931476 
Product Classification Gynocological catheter - Product Code MOV
ProductModified 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.
FEI Number 3005990734
Recalling Firm/
Manufacturer		 Cook Women'S Health
1100 W Morgan St
Spencer IN 47460-9426
For Additional Information ContactJulie 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
ActionCook 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 Commerce721 both products
DistributionUSA, Ireland, China, Canada, India, Australia, Hong Kong.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = MOV
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