Recall Z-0906-2023 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Tonsillectomy Tray, REF 89-10698.01
| Date | Jan 5, 2023 (initiated Nov 28, 2022) |
| Status | Terminated |
| Reason | DeRoyal is recalling certain lots of surgical procedure pack products that contain a ConMed Foot Controlled Electrosurgical Suction Coagulator. The recall is due to ConMed receiving reports that the suction ports may be occluded on the affected devices. If this occurs, the affected devices will not be able to perform the suction function during use. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal issued an URGENT! DEROYAL RECALL NOTICE on 11/28/2022 to the distributor by email and to the end used by overnight USPS. The notice explained the problem and requested the following actions be taken: 1) Using the attached Affected Products Listing, identify affected surgical pack numbers in your inventory and place in quarantine to prevent further use. Please return the packs that you have in inventory to us. You will be given credit or replacement for the returned product. 2) Complete the NOTICE OF RETURN FORM, indicating all affected products found in your inventory. Please retu |
| Quantity | 320 units |
| Distribution | Distribution in US states of VA, and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.