Recall Z-1125-2013— Instrumentation Industries Inc
Class II · Terminated
Class II FDA medical device recall by Instrumentation Industries Inc, initiated 2012-09-07, terminated 2013-07-05. It names one FDA 510(k) clearance: K991785. 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.. Reason: Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use..
- Recalling firm
- Instrumentation Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-07
- Terminated
- 2013-07-05
- Firm location
- Bethel Park, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Reason for recall
Firm initiated an update to Directions for Use necessitating replacement of previously distributed Directions for Use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.