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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Instrumentation Industries Inc
- Reason for Recall:
- Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1125-2013
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