Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for diagnostic ultrasound imaging or fluid flow analysis of the human body.
FDA Recall Z-2782-2011 · Posted 2011-07-11
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Recalling FirmBard Access Systems
Recall StatusTerminated
Product CodeIYN
Date Initiated2011-06-21
Date Terminated2012-07-11
Product Quantity86 units
Reason for Recall
Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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