Recall Z-1250-2022 ยท FDE Laparoscopy Kit
ROi CPS LLC
Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm
| Date | May 3, 2022 |
| Status | Terminated |
| Reason | Potential for the tip of the electrode to detach during use. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent out a recall notification on 05/03/2022 via email as well as the supplier's recall notice and label template to be used to label affected kits in the consignee's inventory. The recall notification letter informs the consignee to check their inventory, quarantine affected units, label affected kits, reply to the response form, and notify customers that were sent affected product. End users are to remove the affected items and discard them. |
| Quantity | 125 units |
| Distribution | Distributed to North Carolina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952204 | CONMED/ASPEN LABS COATED LAPAROSCOPIC ELECTROSURGICAL BLADES Conmedcorp, May 25, 1995 |