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

AngioTouch Kit Model H1000P Hand Controller kits used with the ACIST Contrast Management System.

FDA Recall Z-1002-04 · Posted 2004-07-20

Recalling FirmAcist Medical Systems
Recall StatusTerminated
Product CodeDXT
Date Initiated2004-05-19
Date Terminated2005-11-03
Product Quantity3590 kits

Reason for Recall

Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile.

Firm Action

Each consignee was contacted by telephone and asked to return unused kits with the affected lot number.

Root Cause

Other

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K984231ANGIOGRAPHIC CONTRAST MANAGEMENT SYSTEM, MODEL PART A AND PART BInvasatec · 2000-05-31K991103MODIFICATION TO ACIST CL 100HAcist Medical Systems · 2000-05-31

Official Source

View FDA Recall →

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

↑