16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device
FDA device recall Z-2277-2012 · posted 2012-08-27 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- 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.
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- MSD
- Quantity affected
- 120 units
- Distribution
- National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
- Date initiated
- 2012-08-07
- Date posted
- 2012-08-27
- Date terminated
- 2013-01-07
- Location
- Salt Lake City, UT
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