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Recall Observatory FDA recall evidence

Device product

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.

Z-2212-2016

July 01, 2016

Class I

Product summary

Firm
Carefusion 2200 Inc
Event
Event 74465
Status
Terminated
Classification
Class I
Quantity
10
Official record key
device-enforcement:Z-2212-2016

Official wording

Reason: 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

Code information: Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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