Z-2700-2017 Class II Terminated
FDA device recall Z-2700-2017 was initiated by CareFusion 303, Inc. on June 12, 2017 and is designated Class II. Reason for recall: There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100. The recall status is terminated (terminated January 28, 2019). Affected quantity: 35,940 units.
Recall Details
- Product Type
- Devices
- Report Date
- July 19, 2017
- Initiation Date
- June 12, 2017
- Termination Date
- January 28, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,940 units
Product Description
Alaris Pump Module model 8100
Reason for Recall
There is a potential risk that could cause unintended flow in the older, centered sear door latch design in the Alaris Pump module model 8100.
Distribution Pattern
US and Canada
Code Information
Notification will be distributed to all Alaris Pumps customers with pumps manufactured between June 2002 through June 2004.