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Recall Observatory FDA recall evidence

Device product

16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is made of radio-opaque polyurethane and allows for flow rates as high as 500 ml/min during hemodialysis treatment.

Z-2277-2012

August 07, 2012

Class III

Product summary

Firm
Bard Access Systems
Event
Event 62780
Status
Terminated
Classification
Class III
Quantity
120 units
Official record key
device-enforcement:Z-2277-2012

Official wording

Reason: Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.

Code information: Product Code 5883730 lot number REVK0125.

Distribution pattern: National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 10/2013.