Recall Z-1370-2019 ยท KOB Catheter, Suprapubic (And Accessories)
Cook Inc.
Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774
| Date | Apr 22, 2019 |
| Status | Terminated |
| Reason | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting. |
| Root cause | Error in labeling |
| Action | Cook issued MEDICAL DEVICE CORRECTION letters via courier to US Consignees on April 22, 2019. The letter provides reason for recall, products affected, health risk, action to take: Understand that stent knotting is a potential complication associated with use of the Kwart Retro-Inject" Stent Set and Salle Intraoperative Pyeloplasty Stent Set and should be considered if significant resistance is encountered during attempts at removal. 2. Please maintain a copy of this notice with the current IFU or product(s) in your inventory. 3. If you have affected product in inventory, you may continue to u |
| Quantity | 3711 |
| Distribution | Nationwide Foreign: Australia Canada Austria Belgium Denmark Germany Spain Finland France Martinique French Polynesia Switzerland Ireland Italy Netherlands Poland Sweden United Kingdom Hong Kong New Zealand Chile Colombia Israel Russian Federation Czech Republic Greece Jordan Slovakia South Africa U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K810368 | VANCE PERCUTANEOUS MALECOT NEPHROSTOMY Vance Products, Inc., Mar 20, 1981 |