Recalls / —
—#30444
Product
Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)
- FDA product code
- FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources)
- Device class
- Class 1
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Part Number: 7204823, Camera Coupler, C-Mount, 30mm F.L. Serial Numbers (SR prefix): 8632 8646 8652 8659 8670 8679 8693 8709 8714 8633 8647 8655 8660 8675 8686 8694 8711 8716 8635 8648 8657 8665 8676 8687 8712 8727 8636 8649 8658 8668 8677 8691 8707 8713 8728 Part Number: 7204823S, Camera Coupler, C-Mount, 30mm F.L. Serial Number SR8705
Why it was recalled
Hardware of the camera coupler may rust and result in an ineffective sterilization/cleaning process.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Smith & Nephew notified direct accounts by letter on 10/15/03. Service representatives will remove and replace product.
Recalling firm
- Firm
- Smith And Nephew, Inc. Endoscopy Division
- Address
- 150 Minuteman Rd, Andover, Massachusetts 01810-1031
Distribution
- 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.
Timeline
- Recall initiated
- 2003-10-10
- Posted by FDA
- 2003-12-18
- Terminated
- 2016-01-28
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #30444. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.