Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.
FDA Recall Z-1137-2010 · Posted 2010-03-15
Recalling FirmCook Women'S Health
Recall StatusTerminated
Product CodeMOV
Date Initiated2010-01-08
Date Terminated2010-12-10
Product Quantity721 both products
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.