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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-1138-2010
Recall Event ID 54231
510(K)NumberK931476 
Product Classification Gynocological catheter - Product Code MOV
ProductModified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.
Code Information U1705449, U1707347, U1709250, U1711011, U1714331, U1734602, U1737151, U1743919, U1746659, U1746660, U1755767, U1772781, U1772782, U1791573, U1792176, U1793188, U1799467, U1825725, U1825726, U1841365, U1862710 and U1863536.
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 Commerce2875
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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