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

XVIVO Perfusion AB (Part of Vitrolife), THAM Solution, 3.3 mmol/ml, 50 mL, REF 99019, Sterile, Used to increase the pH of the Perfadex used for perfusion of donor lungs. Perfadex with THAM kits, 8 x 1000mL REF 19017, and 2 x 2800mL REF 19018.

FDA Recall Z-2795-2011 · Posted 2011-07-12

Recalling FirmVitrolife, Inc.
Recall StatusTerminated
Product CodeMSB
Date Initiated2011-05-12
Date Terminated2011-07-15
Product Quantity1457 bottles

Reason for Recall

Precipitation observed in some bottles of Tham buffer used for adjusting pH of Perfadex prior to perfusion of donor lungs.

Firm Action

XVIVO Perfusion, part of the Vitrolife Group, sent out a "Partial recall of Perfadex with THAM" letter on May 13, 2011 to all affected customers. Customers were instructed to to quarantine all Perfadex with THAM. Replacement THAM was to be shipped by Vitrilife within a few days and the exchanged THAM was to immediately sent to Vitrolife, Englewood, CO. For additional Information please call (303) 762-1933

Root Cause

Process control

Distribution Pattern

Worldwide distribution including USA and Europe.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K081997PERFADEX WITH THAMVitrolife Sweden AB · 2008-10-09

Official Source

View FDA Recall →

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

↑