—#50874

Product

Smith & Nephew Suture Passer 2 inch Part Number : 7209167

FDA product code: NBW — System, Test, Blood Glucose, Over The Counter
Device class: Class 2
Medical specialty: Clinical Chemistry
Affected lot / code info: All lot codes

Why it was recalled

Product is labeled as reusable but there is a potential that the cannulated handle of the product cannot be cleaned adequately following use.

Root cause (FDA determination)

Other

Action the firm took

Smith & Nephew notified accounts by letter on 3/1/07, users are advised to destroy product and return unused product in their inventory. A reply form is required to be completed.

Recalling firm

Firm: Smith & Nephew, Inc. Endoscopy Division
Address: 150 Minuteman Drive, Andover, Massachusetts 01810-1031

Distribution

Distribution pattern: World wide- USA and Canada, Belgium. Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Italy, Netherlands, Portugal, Austria, Ireland, Sweden, Argentina. Chile, Columbia, Brazil, China. Japan, Korea, Thailand, Hong Kong, Malaysia. Taiwan, Singapore, India, , Dubai, Mexico, Australia, Egypt. Switzerland, New Zealand and Norway

Timeline

Recall initiated: 2007-03-01
Posted by FDA: 2007-04-07
Terminated: 2008-07-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #50874. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.