Cook Inc. Recall: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN
Cook Inc. Recall: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cook Inc.; Product: Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700
| Recalling firm | Cook Inc. |
|---|---|
| Product | Cook Kwart Retro-Inject Ureteral Stent Set: PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr 003500 G14916; 6.0 Fr 003600 G14836; 7.0 Fr 003700 G14837; 8.0 Fr 003800 G14844; Set with AQ¿ Hydrophilic Coating PRODUCT/CATALOG NUMBER/GPN: 4.7 Fr AQ-003500 G17150; 6.0 Fr AQ-003600 G17151; 7.0 Fr AQ-003700 G17152 |
| Reason for recall | Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set Instructions for Use (IFU) did not include a warning for stent knotting. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| 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 |
| Recall initiated | 20190422 |
| Recall number | Z-1369-2019 |
| Category | device |
| State | IN |
| Country | United States |
$29/mo
Try RecallGuard →