Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

The Companion ClearStar Pump System, for enteral feeding.

FDA Recall Z-1142-2007 · Posted 2007-08-07

Recalling FirmRoss Products Division Abbott Laboratories
Recall StatusTerminated
Product CodeLZH
Date Initiated2007-06-21
Date Terminated2012-09-26
Product Quantity27,814

Reason for Recall

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

Firm Action

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

Root Cause

Equipment maintenance

Distribution Pattern

Worldwide, including USA and Canada.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K981541CLEARSTAR ENTERAL NUTRITION PUMPFrantz Medical Development, Ltd. · 1998-08-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑