Recall Z-1837-2015 ยท LRO General Surgery Tray
DeRoyal Industries Inc
Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO TRAY, REF 50-12127; NEURO SPINE TRAY, LAP CHOLE TRACECART(R), REF 53-1931; MINOR PROCEDURE TRACECART (R), REF 53-1932; MAJOR PROCEDURE TRACECART (R), 53-1933; Cover Light Handle Flexible, REF 5-3479-1; LAPAROSCOPY TRAY, REF 89-3605; KNEE/ARTHROSCOPY TRAY, REF 89-3606; SHOULDER/ARTHROSCOPY TRAY, REF 89-3607; LOWER EXT
| Date | Jun 25, 2015 (initiated Apr 27, 2015) |
| Status | Terminated |
| Reason | Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves which were recalled for splits or holes |
| Root cause | Nonconforming Material/Component |
| Action | The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 4/27/2015 to their customers (i.e., end-user level, its direct accounts and hospitals) via overnight on 04/27/2015. The letters described the product, problem and actions to be taken. The customers were instructed to do the following: a. send Recall Instructions and a listing of their accounts who were shipped affected product (also included were labels, Training forms, Record of Destruction Forms) b. notify Distributors and Hospitals with a list of products shipped to their account with instructions to place any remain |
| Quantity | 235,785 units |
| Distribution | Worldwide Distribution: US (nationwide) and country of Guatemala. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.