Recall Z-2250-2016 ยท FSY Light, Surgical, Ceiling Mounted
Centurion Medical Products Corporation
Convenience Kits from Centurion that contain a Medtronic/Covidien Light Glove ED SUTURE KIT VAGINAL DELIVERY TRAY ENDOSCOPY TRAY MINOR BASIN SET LAPAROSCOPIC BASIN TRAY
| Date | Apr 29, 2015 |
| Status | Terminated |
| Reason | Kits from Centurion contain a Medtronic/Covidien Light Glove that is being recalled by the manufacturer, Medtronic. According to the notice received from Medtronic, the recall was initiated because some light covers may have splits or holes, which may result in the transfer of microorganisms from the light handle into the patient wound. |
| Root cause | Nonconforming Material/Component |
| Action | On 4/28/2015, URGENT PRODUCT RECALL NOTICE notifications were sent to the affected customers via certified mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. |
| Quantity | 483 |
| Distribution | KS, IN, IA, KY, MT, SD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.