Smith & Nephew Endocoupler C-Mount 35 mm Focal Length Reference :7204614 and 7204614S (S indicates unit previously servi
FDA device recall Z-0248-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- Smith And Nephew, Inc. Endoscopy Division
- Reason for recall
- Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
- Action taken
- Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FEM
- Quantity affected
- 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,
- Date initiated
- 2003-10-10
- Date posted
- 2003-12-18
- Date terminated
- 2016-01-28
- Location
- Andover, MA
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