535D-X CF Continuous Flow 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-0732-2007
- 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 535D-M6-CF, serial numbers 06195A051 through 06276B225; Model 535D-ML6-CF, serial numbers 06198A026 through 06277B196; Model 535D-C-CF, serial numbers 06230A008 through 06230A124; Model 535D-D-CF, serial numbers 06230A001 through 06262B126; and Model 535D-E-CF, serial numbers 06230A055 through 06313B122.
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.