NxStage Cartridge Express, CAR-170, for hemodialysis.
- Company
- Nxstage Medical, Inc.
- Recall Initiated
- July 27, 2007
- Posted
- September 20, 2007
- Terminated
- September 13, 2010
- Recall Number
- Z-1228-2007
- Quantity
- 12,085 cases
- Firm Location
- Lawrence, MA
Reason for Recall
Potential for dialysate leaks from the cartridge during treatment.
Distribution
Nationwide
Lot / Code Info
Lot Numbers: 7037802, 703803, 703804, 7047702, 7047703, 7047704, 7047705, 7057702, 7057703, 7057704, 7057705, 7057706, 7057707, 7057708, 7057709, 7067701, 7067702,7067703, 7067705, 7067709, 7067710, 7067711, 7067712, 7067713, 7067714, 7067715, 7077703.
Root Cause
Process change control
Action Taken
NxStage initiated the recall by letter on 8/24/07 advising users of the specific lots to be removed from use. Prior notifications were issued on July 27, 2007, July 30, 2007 and July 31, 2007 notifying users of the potential for leaks and instructions to detect leaks prior to use.
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