Z-1142-2007

The Companion ClearStar Pump System, for enteral feeding

Name: Z-1142-2007 The Companion ClearStar Pump System, for enteral feeding
Creator: Ross Products Division Abbott Laboratories
Published: 2007-06-21
License: https://open.fda.gov/license/

Ross Products Division Abbott Laboratories / initiated 2007-06-21 / Terminated / root cause: manufacturing process

FDA source

Ross Products Division Abbott Laboratories began a recall of The Companion ClearStar Pump System, for enteral feeding on 2007-06-21. The reason FDA records is "The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1142-2007
Status: Terminated
Initiated: 2007-06-21
Posted: 2007-08-07
Terminated: 2012-09-26
Recalling firm: Ross Products Division Abbott Laboratories
Product: The Companion ClearStar Pump System, for enteral feeding.
Product code: LZH Pump, Infusion, Enteral
Reason for recall: The transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Consignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007.
Quantity in commerce: 27,814
Distribution: Worldwide, including USA and Canada.
Product codes and lots: List #55238 & 55239

Product code LZH

K981541Class IIClearstar Enteral Nutrition PumpFrantz Medical Development, Ltd. / cleared 1998-08-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)