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

Anestar Anesthesia Delivery System

FDA Recall Z-1441-04 · Posted 2004-09-09

Recalling FirmDatascope Corp
Recall StatusTerminated
Product CodeBSZ
Date Initiated2003-06-24
Date Terminated2006-10-03

Reason for Recall

Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.

Firm Action

A Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.

Root Cause

Other

Distribution Pattern

The units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.

Official Source

View FDA Recall →

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

↑