16 Fr HemoStar XK Long-Term Hemodialysis Catheter — Class III medical device recall Z-2277-2012
Terminated recall by Bard Access Systems, reported 2012-09-05, distributed in AL, AR, AZ, FL, KS, LA, MA, MI…. Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they we
| Recall number | Z-2277-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bard Access Systems, Salt Lake City, UT, United States |
| Recall initiated | 2012-08-07 |
| Classified | 2012-08-27 |
| Reported by FDA | 2012-09-05 |
| Terminated | 2013-01-07 |
| Distributed | AL, AR, AZ, FL, KS, LA, MA, MI, MO, NC, NJ, OH, OK, OR, TX, WA |
| Quantity | 120 units |
| Reason classes | labeling |
| Lot numbers | REVK0125 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2277-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.