| | Class 1 Device Recall BioMed Devices |  |
| Date Initiated by Firm | December 06, 2004 |
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| Date Posted | January 29, 2005 |
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| Recall Status1 |
Terminated 3 on November 21, 2005 |
| Recall Number | Z-0428-05 |
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| Recall Event ID |
30580 |
| Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
|
| Product | Pneumotach, Disposable (B)
Catalog Number: 4408
Labeled in part:
SINGLE USE CATALOG NO.4408
PNEUMOTACH, DISPOSABLE (B)
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CONTENTS:
1- PNEUMOTACH HEAD ASSEMBLY 1- PARATUBE 60''
2- TUBING FITTINGS
1- 22x22mm ADAPTER |
|---|
| Code Information |
Lot Numbers: 05092204, 05101104, 05101304, 05101404 05102004, 05102604, 05102804, 05110204 05110304, 05110904, 05111804, 05112404 05120104 |
| FEI Number |
3003952420
|
Recalling Firm/
Manufacturer |
Bio-Med Devices, Inc.
1445 Boston Post Road
Guilford CT 06437-4338
|
| For Additional Information Contact | Ken Close
203-458-0202 |
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Manufacturer Reason
for Recall | Adapters may be occluded potentially preventing inhalation |
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FDA Determined
Cause 2 | Other |
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| 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 |
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| Quantity in Commerce | 107 cs |
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| Distribution | Nationwide
Forign: Canada, Greece, Japna, Israel, Saudi Arabia, |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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