Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN.
FDA device recall Z-1137-2010 · posted 2010-03-15 · Terminated
Recall details
- Recalling firm
- Cook Women'S Health
- Reason for recall
- The distal tip may separate from the catheter while the catheter is in the patient.
- Action taken
- 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
- Status
- Terminated
- Product code
- MOV
- Quantity affected
- 721 both products
- Distribution
- USA, Ireland, China, Canada, India, Australia, Hong Kong.
- Date initiated
- 2010-01-08
- Date posted
- 2010-03-15
- Date terminated
- 2010-12-10
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVY CORNUAL CANNULATION SET (K931476) | Cook Ob/Gyn | 1995-07-28 |