FDA Recall Terminated

The Companion ClearStar Pump System, for enteral feeding.

Recall: Z-1142-2007 · Initiated June 21, 2007

Recall

Recall Number
Z-1142-2007
Event Number
38223
Firm
Ross Products Division Abbott Laboratories
FEI Number
1000136098
Product Code
LZH
Status
Terminated
Root Cause
Equipment maintenance
Initiated
June 21, 2007
Posted
August 7, 2007
Terminated
September 26, 2012
Address
6480 Busch Blvd, Columbus, OH, 43229-1756

Description

The Companion ClearStar Pump System, for enteral feeding.

Reason

The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.

Action

Consignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007.

Distribution

Worldwide, including USA and Canada.

Quantity

27,814