FDA Recall
Terminated
DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Recall: Z-0731-2007
·
Initiated January 24, 2007
Recall
- Recall Number
- Z-0731-2007
- Event Number
- 37189
- Firm
- Sunrise Medical
- FEI Number
- 2515872
- Product Code
- NFB
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 24, 2007
- Posted
- April 21, 2007
- Terminated
- August 27, 2009
- Address
- 100 Devilbiss Dr, Somerset, PA, 15501-2125
Description
DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Reason
Cylinder could lose oxygen at high pressure after the filling process
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.
Distribution
Worldwide-original shipments to distributors/dealers USA and Canada.
Quantity
4,169 units (Z-0731/0732-2007)