CLASS I Device recall · Reported 3 Aug 2016 · FDA Enforcement Report

Diamond-flex Circular Retractor, Angled, Product recalled

Carefusion 2200 is recalling Diamond-flex Circular Retractor, Angled, Product, distributed in Maryland, Washington. The recall was initiated on 1 Jul 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16

Quantity recalled10

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2212-2016
FDA event ID: 74465
Recalling firm: Carefusion 2200, Vernon Hills, IL
Classification: Class I
Status: Terminated
Recall initiated: 1 Jul 2016
FDA classified: 22 Jul 2016
Reported: 3 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Surgical Instruments

Timeline

1 Jul 2016	Recall initiated by company
22 Jul 2016	Classified by FDA	+21 days
3 Aug 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Maryland Washington

Questions about this recall

Is Diamond-flex Circular Retractor, Angled, Product recalled?

Yes. Carefusion 2200 recalled Diamond-flex Circular Retractor, Angled, Product on 1 Jul 2016. The recall is Class I and its status is Terminated. Recall number Z-2212-2016.

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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