Enforcement Report - Week of September 5, 2012
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Event Detail
| Event ID | 62780 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Bard Access Systems |
| City | Salt Lake City |
| State | UT |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-08-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | National US distribution only: MO, KS, AZ, OK, OR, AL, MA, TX, FL, MI, OH, LA, NJ, NC, WA, AR. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Product Code 5883730 lot number REVK0125. | Class III | 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. | 120 units | Z-2277-2012 |
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