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Terminated

Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.

FDA Recall Z-1138-2010 · Posted 2010-03-15

Recalling FirmCook Women'S Health
Recall StatusTerminated
Product CodeMOV
Date Initiated2010-01-08
Date Terminated2010-12-10
Product Quantity2875

Reason for Recall

The distal tip may separate from the catheter while the catheter is in the patient.

Firm 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.

Root Cause

Process control

Distribution Pattern

USA, Ireland, China, Canada, India, Australia, Hong Kong.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931476NOVY CORNUAL CANNULATION SETCook Ob/Gyn · 1995-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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