FDA Medical Device Recalls (openFDA)
Bio-Med Devices, Inc.: Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
- Recall number
- Z-0426-05
- Recalling firm
- Bio-Med Devices, Inc.
- Product
- Bio Med Devices Patient Breathing Circuit Catalog Number: 8002A-7 Labeled in part: ONE SET - SINGLE USE ATALOG NO. 8002A-7 PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx60'' 1-EXHALATION VALVE LINE 1/8''IDx90'' 1-PATIENT HOSE 22mmIDx18'' 1-PATIENT HOSE 22mmIDx6'' 1-PRESSURE GAGE LINE 84'' w/CUFF 1/4''ID 1-EXHALATION VALVE w/HOLDING ARM& COLLECTION HEAD 1-ADULT PRESSURE TEE w/CUFF 3-ADAPTERS 22mmx22mm
- Status
- Terminated
- Initiated
- 2004-12-06
- Posted
- 2005-01-29
- Terminated
- 2005-11-21
- Reason
- Adapters may be occluded potentially preventing inhalation
- Root cause
- Other
- Action
- Bio-Med Devices issued recall notifcation by fax on 12/7/04. Accounts are requested to discontine use and return product. A Press Release issued to AP 12/8/04
- Quantity
- 71 cs
- Distribution
- Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
- Lot, serial or model codes
- Lot Numbers: 05092304, 01092804, 01100104, 05100504 01100604, 05100704, 05101204, 01101304 05102104, 01102504, 01102604, 09102704 09102804, 09110404, 01110404, 09110504 09110904, 02111004, 09111104, 09111204 09111504, 09112304, 09112904, 09113004 09120104
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CBK
- 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