FDAClass IAugust 3, 2016

Diamond-flex Circular Retractor recall

DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract…

Why was Diamond-flex Circular Retractor 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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Carefusion 2200 Inc
Quantity
10
Distribution
Worldwide Distribution - US, including the states of WA and MD; and, the country of Japan.
Recall date
August 3, 2016
Classification
Class I
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls