Events

Recall of Manual Jet Ventilators, Manual Jet Ventilators w/Regulator and Guage, Small Bore Tubing Assembly

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instrumentation Industries Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64568
  • Event Risk Class
    Class 2
  • Event Number
    Z-1125-2013
  • Event Initiated Date
    2012-09-07
  • Event Date Posted
    2013-04-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116501
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Ventilator, emergency, powered (resuscitator) - Product Code BTL
  • 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.

Device

Manual Jet Ventilators, Manual Jet Ventilators w/Regulator and Guage, Small Bore Tubing Assembly
  • Model / Serial
    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.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Instrumentation Industries Inc

Manufacturer

Instrumentation Industries Inc