Reported Sep 5, 2012 · Terminated
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device…
Bard Access Systems
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bard Access Systems · 605 North 5600 West · Salt Lake City, UT · 84116-3738
Is this the product you have?
- 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.
- Lot codes and dates
- Product Code 5883730 lot number REVK0125.
- Amount recalled
- 120 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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