Instrumentation Industries Inc recalls Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet Ven

Recalled April 24, 2013 · FDA recall Z-1125-2013 · Instrumentation Industries

Hazard

Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use. · FDA Class II

Units

2998

Sold at

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.

Description

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

Product

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.

Manufacturer(s)

Instrumentation Industries Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →