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Terminated

Smith & Nephew Endocoupler C-Mount 30mm Focal Length Reference: 7204823 and 7204823S (S indicates unit previously serviced)

FDA Recall Z-0247-04 · Posted 2003-12-18

Recalling FirmSmith And Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeFEM
Date Initiated2003-10-10
Date Terminated2016-01-28
Product Quantity35 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.

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