FDA-Device2016-08-03Class I
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Carefusion 2200 Inc
Hazard
BD, formerly CareFusion, has identified a potential risk associated with a weld failure which could result in the wire protruding thru the tip of the instrument when articulated. If this failure were to occur while in use in a procedure it has the potential to damages tissue or organs
Sold states
Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Affected count
10
Manufactured in
75 N Fairway Dr, N/A, Vernon Hills, IL, United States
Products
DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue to provide better visualization access.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2212-2016Don't want to check this manually?
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