Reported Apr 24, 2013 · Terminated

Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators; BE 183-SUR and BE 183 SUR-12 Manual Jet…

Instrumentation Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Instrumentation Industries Inc · 2990 Industrial Blvd · Bethel Park, PA · 15102-2536

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.

Lot codes and dates: 313 of 313 codes
BE 183-2 -- lot numbers P0911307
P1109307
P1117907
P1210807
P1216107
P0112208
P0203508
P0208308
P0220008
P0313608
P0503608
P0510108
P0712408
P0816308
P0911708
P1008408
P0115009
P0203009
P0313109
P0603709
P0619009
P0806309
P0903509
P0905109
P0912309
P1005709
P1107809
P1205709
P1214309
P0111410
P0210810
P0212510
P0300210
P0314310
P0400710
P0404510
P0701210
P0705410
P0715010
P0816310
P0715010R10
P0705410R10
P1001810
P1011610
P1114810
P1204810
P1207310
P0109811
P0211311
P0404611
P0504911
P0603911
P0706511
P0801811
P0811811
P0818511
P0900611
P0908411
P0917111
P1008111
Amount recalled: 2998

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

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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