| Date Initiated by Firm | October 02, 2003 |
|---|
| Date Posted | October 24, 2003 |
|---|
| Recall Status1 |
Terminated 3 on January 06, 2006 |
| Recall Number | Z-0056-04 |
|---|
| Recall Event ID |
27188 |
| 510(K)Number | K010747 |
|---|
| Product Classification |
Ventilator, Non-Continuous (Respirator) - Product Code BZD
|
| Product | Western Medica OPC Portable Oxygen Conserving Regulator, Model MDL-7609, 1/2 - 5 LPM, packaged under the Medline label. |
|---|
| Code Information |
Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881'' |
| FEI Number |
1526809
|
Recalling Firm/
Manufacturer |
Western a Scott Fetzer Co
875 Bassett Rd
Westlake OH 44145
|
| For Additional Information Contact |
440-871-2160 |
|---|
Manufacturer Reason
for Recall | The demand valve is defective and does not function as intended in the 'Conservative Mode'. |
|---|
FDA Determined
Cause 2 | Other |
|---|
| Action | The firm notified the affected consignees by letter on 10/2/2003. Customers were asked to return the units for replacements. |
|---|
| Quantity in Commerce | 1,106 units |
|---|
| Distribution | The device was distributed nationwide and into China and Japan. |
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| 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.
|
| 510(K) Database | 510(K)s with Product Code = BZD
|
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