Recall Z-0637-2018 ยท LRO General Surgery Tray
DeRoyal Industries Inc
Custom sterile surgical packs labeled as follows: GEO-MED CABG PACK PGYBK A & B, REF 89-5985.07, STERILE EO Use: Shoulder Arthroscopy
| Date | Jan 22, 2018 |
| Status | Terminated |
| Reason | DeRoyal manufactured custom sterile surgical kits containing the Terumo Over Pressure Safety Valve, which were subsequently recalled by Terumo CVS due to reports of 'No Flow' through the OPS valve. |
| Root cause | Process change control |
| Action | The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 01/22/18 to its Consignees on 1/22/18 by overnight mail. The firm sent a follow-up "URGENT! RECALL NOTICE" letter dated 1/29/18. The letters described the product, problem and actions to be taken. The Consignees were instructed to identify affected products; place in quarantine; complete and return the Notice of Return Form, even if they no longer held any affected product, to DeRoyal via fax to 865-362-3716 or email to recalls@deroyal.com no later than 3/1/18, and return any product they held in stock. If you have further distri |
| Quantity | 181 units |
| Distribution | US Distribution to: NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |