Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or
FDA device recall Z-2782-2011 · posted 2011-07-11 · Terminated
Recall details
- Recalling firm
- Bard Access Systems
- Reason for recall
- Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 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.
- Date initiated
- 2011-06-21
- Date posted
- 2011-07-11
- Date terminated
- 2012-07-11
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SITE-RITE VISION ULTRASOUND SYSTEM (K100402) | Bard Access Systems, Inc. | 2010-03-05 |