| Date Initiated by Firm | December 06, 2004 |
|---|
| Date Posted | January 29, 2005 |
|---|
| Recall Status1 |
Terminated 3 on November 21, 2005 |
| Recall Number | Z-0429-05 |
|---|
| Recall Event ID |
30580 |
| Product Classification |
Ventilator, Continuous, Facility Use - Product Code CBK
|
| Product | Bio-Med Patient Breathing Circuit
Product NUmber: 3030-5
Labeled in part:
ONE SET - SINGLE USE CATALOG NO. 3030-5
PATIENT BREATHING CIRCUIT
=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=-=
CONTENTS:
1-PATIENT HOSE 22mmIDx60''
1-PRESSURE GAGE LINE 1/8''IDx72''
1-PATIENT HOSE 22mmIDx6''
1-EXHALATION VALVE w/COLLECTION HEAD
1-ADULT PRESSURE TEE w/CUFF
1-EXHALATION VALVE LINE 1/8''IDx72
2-ADAPTERS 22mmx22mm |
|---|
| Code Information |
Lot Number: 09111704 |
| 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 |
|---|
Manufacturer Reason
for Recall | Adapters may be occluded potentially preventing inhalation |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 2 cs |
|---|
| Distribution | Nationwide
Forign: Canada, Greece, Japna, Israel, Saudi Arabia, |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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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