Z-2277-2012Class III

16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer...

Name: Z-2277-2012 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer...
Creator: Bard Access Systems
Published: 2012-08-07
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2012-08-07 / Terminated

FDA source

Bard Access Systems began a recall of 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring... on 2012-08-07. FDA classified it as Class III and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2277-2012
Classification: Class III
Status: Terminated
Initiated: 2012-08-07
Posted: 2012-08-27
Terminated: 2013-01-07
Recalling firm: Bard Access Systems, Inc.
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.
Product code: MSD Catheter, Hemodialysis, Implanted
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.
FDA root cause: Incorrect or no expiration date
Action: Bard Access Systems sent an "URGENT: *16 FR HEMOSTAR* LONG-TERM HEMODIALYSIS CATHETER RECALL" letter dated August 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Reply Form and Inventory Reconciliation Form was enclosed for customers to complete and return via fax to 1-801-522-5674. Contact BAS Customer Service at 1-800-290-1689 for questions regarding this recall.
Quantity in commerce: 120 units
Distribution: National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
Product codes and lots: Product Code 5883730 lot number REVK0125.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2277-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2277-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-05	2012-08-27

Product code MSD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)