Date Initiated by Firm |
October 02, 2003 |
Date Posted |
October 24, 2003 |
Recall Status1 |
Terminated 3 on January 06, 2006 |
Recall Number |
Z-0054-04 |
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 OPC-830, 1/2 - 5 LPM, packaged under the Western Medica label. |
Code Information |
Unit S/Ns beginning with ''DHE0010xxxxx'' and ''DHE001100001'' thru ''DHE001102881'' |
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 |
329 units |
Distribution |
The device was distributed nationwide and into China and Japan. |
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 and Original Applicant = WESTERN ENT.
|