FDA Medical Device Recalls (openFDA)
Instrumentation Industries Inc: BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
- Recall number
- Z-0556-04
- Recalling firm
- Instrumentation Industries Inc
- Product
- BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator with Regulator and Gauge.
- Status
- Terminated
- Initiated
- 2003-09-12
- Posted
- 2004-02-27
- Terminated
- 2004-02-26
- Reason
- possible external debris in the on/off plunger.
- Root cause
- Other
- Action
- The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.
- Quantity
- 46 units
- Distribution
- The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.
- Lot, serial or model codes
- Part number BE183-SUR, Lot number P0908103
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 2518436
- Firm city
- Bethel Park
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28