Instrumentation Industries Recalls Manual Jet Ventilators for Updated Directions
Instrumentation Industries is recalling specific manual jet ventilators and accessories to replace previously distributed Directions for Use with updated versions.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for documentation issues (updating Directions for Use) without reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation-only problems.
Plain-English summary
Instrumentation Industries Inc is recalling approximately 2,998 units of 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 Regulators. The recall was initiated by the firm to update the Directions for Use, necessitating the replacement of previously distributed documentation.
The affected products are designed to provide transtracheal ventilation in specific emergency situations of upper airway obstructions. The recall covers units distributed worldwide, including the United States (specific states listed in agency records) and internationally to Canada, Ireland, Hong Kong, the Netherlands, New Zealand, and Thailand. Specific lot numbers for the BE 183-2, BE 183-R, BE183-SU, BE 183-SUR, and BE 183 SUR-12 models are listed in the agency record, while no lot numbers were assigned for the BE 183 SU-12 model.
Consumers and healthcare facilities should check their inventory for the specific model numbers and lot numbers listed in the official recall notice. The primary action required is the replacement of the previously distributed Directions for Use with the updated versions provided by the firm.
The recalled product
- 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…
- Manufacturer
- Instrumentation Industries Inc
- Category
- Medical Device — Ventilators
- Hazard
- Affected units
- 2,998
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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