Recall Z-0426-05 ยท CBK Ventilator, Continuous, Facility Use
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''
| Date | Jan 29, 2005 (initiated Dec 6, 2004) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.