Date Initiated by Firm |
January 24, 2007 |
Date Posted |
April 21, 2007 |
Recall Status1 |
Terminated 3 on August 27, 2009 |
Recall Number |
Z-0731-2007 |
Recall Event ID |
37189 |
510(K)Number |
K020329
|
Product Classification |
Oxygen cylinders - Product Code NFB
|
Product |
DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder |
Code Information |
Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055; Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328; Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922; Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191; Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132; and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267. |
Recalling Firm/ Manufacturer |
Sunrise Medical 100 Devilbiss Dr Somerset PA 15501-2125
|
For Additional Information Contact |
Joseph E. Olsavsky 814-443-7690
|
Manufacturer Reason for Recall |
Cylinder could lose oxygen at high pressure after the filling process
|
FDA Determined Cause 2 |
Other |
Action |
The recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units. |
Quantity in Commerce |
4,169 units (Z-0731/0732-2007) |
Distribution |
Worldwide-original shipments to distributors/dealers USA and Canada. |
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 = NFB and Original Applicant = SUNRISE MEDICAL HHG, INC.
|