FDAJuly 1, 2016device

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 recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

carefusion 2200carefusion

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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