Shent USA, Inc. Recall 88136
Description: Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope
Shent USA, Inc. Recall 88136 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2230-2021 |
| Event ID | 88136 |
| Event Description | Grasper/Retriever, Alligator Jaw, Rat Tooth 2.4 mm x 8 mm x 230 cm Catalog Number: 7226 Intended use: single use accessory devices used through the working channel of a GI endoscope |
| Product Type | Devices |
| Distribution | US Nationwide Distribution - CA, CO, MI Foreign: Australia |
| Quantity | 85 units OUS |
| Recall Reason | Mislabeled: Devices labeled as catalog #7208 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm) may actually be catalog #7226 (Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 8 mm x 230 cm) and Devices labeled as catalog #7226, (Grasper/Retriever, Alligator Jaw, Rat Tooth, 2.4 mm x 8 mm x 230 cm) may actually be catalog #7208, Grasper/Retriever, Alligator Jaw, 2.4 mm x 5 mm x 230 cm). |
| Device Classification | 20210818 |
| Device Code Info | Lot Code: D20177226-19 |
| Center Classification Date | 20210806 |
| Recall Initiation Date | 20210112 |
| Recalling Firm | Shent USA, Inc. |
| Initial Notification | Letter |
| Similar To |