Class II — Instrumentation Industries Inc
| Recalling firm | INSTRUMENTATION INDUSTRIES, INCORPORATED |
|---|---|
| Registered facility | INSTRUMENTATION INDUSTRIES, INCORPORATED (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| Quantity | 2998 |
| 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. |
| Initiated | 2012-09-07 |
| Classified | 2013-04-16 |
| Terminated | 2013-07-05 |
| Recall number | Z-1125-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Instrumentation Industries Inc (Z-1125-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64568/
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