Recall Z-1138-2010 ยท MOV Catheters, Salpingography
Cook Women'S Health
Modified Novy Cornual Cannulation Set with clear tip, G17478, REF J-NCS-503570, Cook OB/GYN.
| Date | Mar 15, 2010 (initiated Jan 8, 2010) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931476 | NOVY CORNUAL CANNULATION SET Cook Ob/Gyn, Jul 28, 1995 |