Reported Aug 3, 2016 · Terminated

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

Carefusion 2200 Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carefusion 2200 Inc · 75 N Fairway Dr · Vernon Hills, IL · 60061-1845

Is this the product you have?

  • DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114
  • Lot Code(s)
    • 878971
    • 879366
    • 879404
  • and Date CodeC16. Designed to retract or elevate organs and tissue to provide better visualization access
Lot codes and dates
  • Product Code 89-6114
  • Lot Code(s)
    • 878971
    • 879366
    • 879404
  • and Date CodeC16
Amount recalled
10

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 29, 2017 · Data as of Sep 19, 5:20 PM UTC

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