FDAFDA · Food and drugs·Recall number Z-2277-2012
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.
Published September 5, 2012 · Recall initiated: August 7, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Bard Access Systems
- Distributor
- National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR.
- Lot
- Product Code 5883730 lot number REVK0125.
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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