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Class 2 Device Recall Novy cornual cannulation set |
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Date Initiated by Firm |
January 08, 2010 |
Date Posted |
March 15, 2010 |
Recall Status1 |
Terminated 3 on December 10, 2010 |
Recall Number |
Z-1138-2010 |
Recall Event ID |
54231 |
510(K)Number |
K931476
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Product Classification |
Gynocological catheter - Product Code MOV
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Product |
Modified 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. |
Recalling Firm/ Manufacturer |
Cook Women'S Health 1100 W Morgan St Spencer IN 47460-9426
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For Additional Information Contact |
Julie Cooper 812-829-4891 Ext. 7241
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Manufacturer Reason for Recall |
The distal tip may separate from the catheter while the catheter is in the patient.
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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 |
2875 |
Distribution |
USA, Ireland, China, Canada, India, Australia, Hong Kong. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = MOV and Original Applicant = COOK OB/GYN
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