Bard Access Systems: Medical Device Recall in 2012 - (Recall #: Z-2277-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.
Product Description:

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.

Product Classification:

Class III

Date Initiated: August 7, 2012
Date Posted: September 5, 2012
Recall Number: Z-2277-2012
Event ID: 62780
Reason for Recall:

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.

Status: Terminated
Product Quantity: 120 units
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.

Voluntary or Mandated:

Voluntary: Firm initiated