Recall Z-2277-2012
Bard Access Systems · initiated August 7, 2012
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Product Code 5883730 lot number REVK0125.
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-determined 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.
Details
- Recall number
- Z-2277-2012
- Initiated
- August 7, 2012
- Posted by FDA
- August 27, 2012
- Terminated
- January 7, 2013
- Product code
- MSD – Catheter, Hemodialysis, Implanted
- Quantity
- 120 units
- Distribution
- National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
- Recalling firm
- Bard Access Systems, Salt Lake City, UT