Recall Z-2277-2012— Bard Access Systems
Class III · Terminated
Class III FDA medical device recall by Bard Access Systems, initiated 2012-08-07, terminated 2013-01-07. FDA's recall record names no specific 510(k) clearance for this event. 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.. 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..
- Recalling firm
- Bard Access Systems
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2012-08-07
- Terminated
- 2013-01-07
- Firm location
- Salt Lake City, UT, United States
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.