FDA Device recall Z-1211-2019
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rot…
- FDA Device
- Class II
- terminated
- Published 2019-05-01
On 2019-05-01 the FDA classified a Class II recall of Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rot… by Covidien, citing sterilization method used was not consistent with the labeling and the approved sterilization method.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1211-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-03-13 |
| Published | 2019-05-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Covidien |
| Distribution | US |
Product
Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidien Endo Clinch" II Auto Suture" grasper 5mm has a 5 mm diameter, rotating, insulated shaft approximately 31 cm in length and is designed for introduction and use through the appropriately sized Covidien" trocar sleeve or larger sized sleeve with the use of a converter. The atraumatic jaws are clamped and locked onto tissue structures by closing the handles
Reason
Sterilization method used was not consistent with the labeling and the approved sterilization method
Identifiers
| code_info | Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PR…Lot Numbers: P8D1333PRX P8D1334PRX P8D1614PRX P8D1615PRX P8D1616PRX P8E1143PRX P8E1189PRX P8E1269PRX P8E1271PRX P8E1272PRX P8F0008PRX P8F1238PRX P8F1239PRX P8F1307PRX P8F1448PRX P8F1452PRX P8F1480PRX P8F1545PRX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1211-2019%22
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