FDA Medical Device Recalls (openFDA)
Cook Women'S Health: Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.
- Recall number
- Z-1138-2010
- Recalling firm
- Cook Women'S Health
- Product
- Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.
- Status
- Terminated
- Initiated
- 2010-01-08
- Posted
- 2010-03-15
- Terminated
- 2010-12-10
- Reason
- The distal tip may separate from the catheter while the catheter is in the patient.
- 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
- 2875
- Distribution
- USA, Ireland, China, Canada, India, Australia, Hong Kong.
- Lot, serial or model codes
- U1705449, U1707347, U1709250, U1711011, U1714331, U1734602, U1737151, U1743919, U1746659, U1746660, U1755767, U1772781, U1772782, U1791573, U1792176, U1793188, U1799467, U1825725, U1825726, U1841365, U1862710 and U1863536.
- 510(k) numbers
- ["K931476"]
- PMA numbers
- not on file
- Product code
- MOV
- Firm FEI
- 3005990734
- Firm city
- Spencer
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28