FDA Device recall Z-2277-2012
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer
- FDA Device
- Class III
- terminated
- Published 2012-09-05
On 2012-09-05 the FDA classified a Class III recall of 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer by Bard Access Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2277-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-08-07 |
| Published | 2012-09-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bard Access Systems |
| Distribution | AL, AR, AZ, FL, KS, LA, MA, MI, MO, NC, NJ, OH, OK, OR, TX, WA |
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.
Identifiers
| code_info | Product Code 5883730 lot number REVK0125. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2277-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.