Recall Z-2230-2021 ยท OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Shent USA, Inc.
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
| Date | Jan 12, 2021 |
| Status | Completed |
| 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). |
| Root cause | Packaging process control |
| Action | Telemed issued Urgent Medical Device Recall letter on 1/12/21. Letter states reason for recall, health risk and action to take: Please respond to this recall notification (email response is acceptable) to let us know whether or not you have any of the recalled product in your inventory. If you are in possession of any recalled devices, please provide the quantity, catalog number and lot number. All affected devices must be returned to TeleMed; upon receiving your response to this notification, TeleMed Customer Service will provide you with an RGA number for product return. If you have any ques |
| Quantity | 85 units OUS |
| Distribution | US Nationwide Distribution - CA, CO, MI Foreign: Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974300 | TELEMED SYSTEMS RETRIEVAL BASKET Telemed Systems, Inc., Dec 19, 1997 |