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.
This recall has been terminated (originally issued August 27, 2012).
- Company
- Bard Access Systems
- Recall Initiated
- August 7, 2012
- Posted
- August 27, 2012
- Terminated
- January 7, 2013
- Recall Number
- Z-2277-2012
- Quantity
- 120 units
- Firm Location
- West Salt Lake City, UT
- Official Source
- View on FDA website ↗
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.
Distribution
National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
Lot / Code Info
Product Code 5883730 lot number REVK0125.
Root Cause
Incorrect or no expiration date
Action Taken
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.