FDA Medical Device Recalls (openFDA)
Bio-Med Devices, Inc.: Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''
- Recall number
- Z-0423-05
- Recalling firm
- Bio-Med Devices, Inc.
- Product
- Bio Med Devices Patient Breathing Circuit Catalog Number: 80011 Labeled in part: '':PATIENT BREATHING CIRCUIT =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1-PATIENT HOSE 22mmIDx42'' 1-PRESSURE GAGE LINE 3/16''IDx54'' 1-PATIENT HOSE 22mmIDx24'' 3-ADAPTERS 22mm x 22mm 1-PATIENT HOSE 22mmIDx6'' 1-ADULT PRESSURE TEE 1-EXHALATION VALVE w/HOLDING ARM& 1-TEMPERATURE ADAPTER 22mmID x 22mm COLLECTION HEAD 2-CUFF 1/4''ID x 5/4'' 1-EXHALATION VALVE LINE 1/8''IDx52''
- 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
- 159 cs
- Distribution
- Nationwide Forign: Canada, Greece, Japna, Israel, Saudi Arabia,
- Lot, serial or model codes
- Lot Numbers: Last 6 digits 01092304, 01092404, 01092804, 01092904, 01093004, 01100504, 01100604, 01100704 01100804, 01101104, 01101204, 01101404 01101504, 02101804, 01101904, 01102004 01102104, 01102204, 01102504, 05102504 01102604, 01102804, 01102904, 01110104 01110204, 01110504, 09111004, 01111104 05111204, 09111604, 01111704, 01111904 01112204, 09112404, 09113004, 09120204
- 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