Carefusion 2200 Inc recalls DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date…

Recall date

July 1, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2212-2016

FDA classification

Class I

Brand / firm

Carefusion 2200 Inc

Sold / distributed

Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.