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U.S. Department of Health and Human Services

Class 3 Device Recall HemoStar XK LongTerm Hemodialysis Catheter

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  Class 3 Device Recall HemoStar XK LongTerm Hemodialysis Catheter see related information
Date Initiated by Firm August 07, 2012
Date Posted August 27, 2012
Recall Status1 Terminated 3 on January 07, 2013
Recall Number Z-2277-2012
Recall Event ID 62780
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
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.
Code Information Product Code 5883730 lot number REVK0125.
Recalling Firm/
Manufacturer		 Bard Access Systems
605 North 5600 West
Salt Lake City UT 84116-3738
For Additional Information Contact Mr. Sean Poplin
801-522-4930
Manufacturer 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 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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