DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
This recall has been terminated (originally issued April 21, 2007).
- Company
- Sunrise Medical
- Recall Initiated
- January 24, 2007
- Posted
- April 21, 2007
- Terminated
- August 27, 2009
- Recall Number
- Z-0731-2007
- Quantity
- 4,169 units (Z-0731/0732-2007)
- Firm Location
- Somerset, PA
- Official Source
- View on FDA website ↗
Reason for Recall
Cylinder could lose oxygen at high pressure after the filling process
Distribution
Worldwide-original shipments to distributors/dealers USA and Canada.
Lot / Code Info
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.
Root Cause
Other
Action Taken
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.