Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

16 Fr HemoStar XK Long-Term Hemodialysis Catheter Recalled by Bard Access Systems Due to Bard Access Systems is recalling one lot of...

Date: August 7, 2012
Company: Bard Access Systems
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bard Access Systems directly.

Affected Products

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.

Quantity: 120 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 16 states: AL, AZ, AR, FL, KS, LA, MA, MI, MO, NJ, NC, OH, OK, OR, TX, WA

Affected (16 states)Not affected

About Bard Access Systems

Bard Access Systems has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report