FDA Recall
Terminated
Embrace Enteral Pump
Recall: Z-1141-2007
·
Initiated June 21, 2007
Recall
- Recall Number
- Z-1141-2007
- Event Number
- 38222
- Firm
- Ross Products Division Abbott Laboratories
- FEI Number
- 1000136098
- Product Code
- LZH
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- June 21, 2007
- Posted
- August 8, 2007
- Terminated
- September 20, 2012
- Address
- 6480 Busch Blvd, Columbus, OH, 43229-1756
Description
Embrace Enteral Pump
Reason
Continued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
Action
Consignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.
Distribution
The product was distributed throughout the US.
Quantity
9,600 units