FDA Medical Device Recalls (openFDA)
Bio-Med Devices, Inc.: MVP-10 Pediatric/ Neonatal Volume Ventilator
- Recall number
- Z-0300-04
- Recalling firm
- Bio-Med Devices, Inc.
- Product
- MVP-10 Pediatric/ Neonatal Volume Ventilator
- Status
- Terminated
- Initiated
- 2003-11-07
- Posted
- 2004-01-06
- Terminated
- 2016-02-01
- Reason
- Two way relief valve may fail to activate at the low negative pressure of -3cm H2O.
- Root cause
- Other
- Action
- Bio Med Devices notified accounts by telephone on 11/7/03, to return the device for replacement and correction.
- Quantity
- 3 units
- Distribution
- ID, PA, TX
- Lot, serial or model codes
- S/N: 3023031, 3025031, 0957951
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MNT
- Firm FEI
- 3003952420
- Firm city
- Guilford
- Firm state
- CT
- 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