BEUDAMED
    FDA Recall Terminated

    Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.

    Recall: Z-1125-2013 · Initiated September 7, 2012

    Recall

    Recall Number
    Z-1125-2013
    Event Number
    64568
    Firm
    Instrumentation Industries Inc
    FEI Number
    2518436
    Product Code
    BTL
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    September 7, 2012
    Posted
    April 16, 2013
    Terminated
    July 5, 2013
    Address
    2990 Industrial Blvd, Bethel Park, PA, 15102-2536

    Description

    Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ventilators with Regulator and Gauge; BE 183-2 4 ft. Small Bore Tubing Assembly w/Inline Filter; and BE 183-R Regulator The BE 183-SUR and BE 183-SU Manual Jet Ventilators are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions.

    Reason

    Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.

    Action

    Instrumentation Industries, Inc. initiated a recall of this product on September 7, 2012 by sending a letter via priority mail to all consignees. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to replace the package insert of any affected product with the enclosed corrected package insert (now at Rev. H). The Directions for Use can alsbe downloaded from their website if they should need additional copies. If the product was further distributed consignees were asked to notify their consignees about this Field Correction. For questions regarding this recall call 412-854-1133.

    Distribution

    Worldwide Distribution - USA including AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, VT, WA, WI and WV. Shipped internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand.

    Quantity

    2998