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.

Completed

Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.

FDA Recall Z-0312-03 · Posted None

Recall StatusCompleted
Date Initiated2002-11-01
Product Quantity356 units

Reason for Recall

Separation between lid and housing unit.

Firm Action

Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.

Distribution Pattern

OH, KY, AL, TN, FL, NY, IL, no government or military accounts

Official Source

View FDA Recall →

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

↑