Z-1138-2010

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

Name: Z-1138-2010 Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN
Creator: Cook Women'S Health
Published: 2010-01-08
License: https://open.fda.gov/license/

Cook Women'S Health / initiated 2010-01-08 / Terminated / root cause: manufacturing process

FDA source

Cook Women'S Health began a recall of Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN on 2010-01-08. The reason FDA records is "The distal tip may separate from the catheter while the catheter is in the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1138-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-03-15
Terminated: 2010-12-10
Recalling firm: Cook Women'S Health
Product: Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.
Product code: MOV Catheters, Salpingography
Reason for recall: The distal tip may separate from the catheter while the catheter is in the patient.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: U1705449, U1707347, U1709250, U1711011, U1714331, U1734602, U1737151, U1743919, U1746659, U1746660, U1755767, U1772781, U1772782, U1791573, U1792176, U1793188, U1799467, U1825725, U1825726, U1841365, U1862710 and U1863536.

Product code MOV

K931476Class IINovy Cornual Cannulation SetCook Ob/Gyn / cleared 1995-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)