Purchasing erroneously ordered the incorrect fan using the distributor's part number instead of using the specified manufacturer part number.
Process control
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.
86 units
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.
TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database
510(K)s with Product Code = IYN and Original Applicant = BARD ACCESS SYSTEMS, INC.