Recall Z-0527-2015 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Alcon Research, Ltd.
Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
| Date | Dec 12, 2014 (initiated Nov 11, 2014) |
| Status | Terminated |
| Reason | The product is sold and labeled as EO sterilized, however the units were not sterilized prior to shipment to customers. |
| Root cause | Process control |
| Action | On November 11, 2014, the firm sent letters to their customers notifiying them of the medical device recall. The recalling firm asked their customers to stop using the recalled product, remove it from inventory, return the affected product, and complete a response form. |
| Quantity | 2321 |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Indonesia, South Africa, Switzerland, Brazil, Kazakhstan, and Pakistan. |
| FDA record | Open on fda.gov |