Recall Z-1753-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Gyrus Acmi, Incorporated
Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
| Date | Jun 11, 2015 (initiated May 8, 2015) |
| Status | Terminated |
| Reason | Potential lack of sterility assurance. |
| Root cause | Under Investigation by firm |
| Action | The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary. |
| Quantity | 22,250 boxes |
| Distribution | Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123429 | OLYMPUS ENERGY POWER SYSTEM (EPS) Gyrus Acmi, Inc., Apr 5, 2013 |