Recall Z-0248-04 ยท FEM Accessories, Photographic, For Endoscope (Exclude Light Sources)
Smith And Nephew, Inc. Endoscopy Division
Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously serviced)
| Date | Dec 18, 2003 (initiated Oct 10, 2003) |
| Status | Terminated |
| Reason | Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process. |
| Root cause | Nonconforming Material/Component |
| Action | Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product. |
| Quantity | 255 units |
| Distribution | Nationwide to hospitals Foreign: Australia, Africa, Belgium, Canada, China, Dubai, Egypt, Germany, D\Godmanchester, Italy, Japan, Korea, Malaysia, Norway, Portugal, Singapore, South Africa, Thailand, Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.