Z-1125-2013 Class II 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.

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

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, P1012211, P1113911, P1207111, P0107712, P0118212, P0211712, P0308512, P0409012, P0412912, P0802012, and P0813612; BE 183-R -- P0904007, P1015407, P1118107, P1209207, P0205608, P0208208, P0415408, P0509608, P0503008, P0517408R, P1215508, P0200709, P0308109, P0614909, P0712009, P0806409, P0903309, P1101909, P1101909R10, P0303710, P0409910, P0615710, P0710710, P0714510, P0814310, P0907010, P1214710, P0208711, P0208711R11, P1214710R11, P0716411, P0718111, P0807511, P0812211, P0816111, P0819511, P0914111, P1000511, P1015011, P1217911, P0117112, P0211312, P0313612, P0605312, P0709612, and P0807812; BE183-SU -- P0914607, P1015607, P1016907, P1119007, P1201807, P1211307, P0108808, P0112408, P0203008, P0208608, P0306908, P0313508, P0404908, P0510008, P0708808, P0806508, P0915908, P1020008, P1104508, P1109108, P1211608, P0102809, P0203109, P0208109, P0214609, P0302209, P0504909, P0603609, P0617209, P0618909, P0703509, P0804609, P0812609, P1005209, P1110009, P1221709, P0104510, P0108110, P0307110, P0411910, P0603510, P0616210, P0813510, P0912310, P1000910, P1017410, P0111111, P0207611, P0209411, P0216411, P0300611, P0309411, P0515711, P0619111, P0707411, P0717311, P0804011, P0809611, P0815311, P0901611, P0905011, P0915611, P1014511, P1103511, P1112811, P1116411, P1201911, P1213511, P1216511, P0103312, P0106212, P0114112, P0207712, P0211112, P0216312, P0320512, P0402512, P0408912, P0416912, P0509212, and P0513212; BE 183 SU-12 -- no lot numbers assigned; BE 183-SUR -- P0908607, P1006707, P1010807R, P1101207, P1117507, P1117707, P1210307, P1212007, P0103208, P0110308, P0116508, P0203208, P0214908, P0221508, P0317708, P0409808, P0409908, P0418308, P0508508, P0513308, P0601308, P0606608, P0704008, P0808108, P0606608R, P0814308, P0907308, P0916208, P1011108, P1016908, P1201708, P1208508, P0102409, P0113809, P0203709, P0102409R09, P0304509, P0405109, P0413009, P0501209, P0612709, P0709109, P0803109, P0910909, P1009609, P1106609, P1111509, P1206809, P1218009, P0114410, P0203010, P0304310, P0408410, P0500610, P0509410, P0607410, P0705710, P0711810, P0500610R10, P0805110, P0903110, P0909710, P1014710, P1102910, P0104411, P0116011, P0201211, P0206711, P0211011, P0219311, P0302911, P0308311, P0312211, P0400211, P0413811, P0506511, P0605911, P0609411, P0703111, P0708011, P0807911, P0809511, P0813811, P0819311, P0901311, P0905311, P0907511, P0912211, P1002711, P1018011, P1102911, P1104011, P1110711, P1207011, P0107812, P0115812, P0208312, P0210912, P0305212, P0309312, P0315812, P0400912, P0407212, P0417012, P0601712, P0701712, and P0712412; and BE 183 SUR-12 -- P1012107, P1102507, P1116107, P0319008, P1113408, P0201409, and P0703911.