Recall Z-0428-05 ยท CBK Ventilator, Continuous, Facility Use
Bio-Med Devices, Inc.
Pneumotach, Disposable (B) Catalog Number: 4408 Labeled in part: SINGLE USE CATALOG NO.4408 PNEUMOTACH, DISPOSABLE (B) =-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-= CONTENTS: 1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60'' 2- TUBING FITTINGS 1- 22x22mm ADAPTER
| 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 | 107 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.