Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously serviced)
FDA Recall Z-0248-04 · Posted 2003-12-18
Recalling FirmSmith And Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeFEM
Date Initiated2003-10-10
Date Terminated2016-01-28
Product Quantity255 units
Reason for Recall
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
Firm Action
Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.
Root Cause
Nonconforming Material/Component
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.