Recall Z-2277-2012 ยท MSD Catheter, Hemodialysis, Implanted
Bard Access Systems
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.
| Date | Aug 27, 2012 (initiated Aug 7, 2012) |
| Status | Terminated |
| 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. |
| 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 | 120 units |
| Distribution | National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.