Recall Z-2782-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Bard Access Systems
Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
| Date | Jul 11, 2011 (initiated Jun 21, 2011) |
| Status | Terminated |
| Reason | Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number. |
| Root cause | Process control |
| Action | Bard Access Systems, Inc sent out an "Urgent" Medical Device Recall (User Level)" dated June 2011 to all affected customers The letter included: product name, description of problem and requested the return of units bearing "B50" on the fan. Bard Access Systems, Inc. will replace the incorrect fan with the correct fan. For additional information call 1-724-779-3000. |
| Quantity | 86 units |
| Distribution | Nationwide (USA) distribution including the states of AL, AR, AZ, CA, CO, FL, IA, IN, MD, MI, MO, MS, NC, NJ, NM, NY, OH, PA, RI, SC, TX, UT, VA, VT, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100402 | SITE-RITE VISION ULTRASOUND SYSTEM Bard Access Systems, Inc., Mar 5, 2010 |