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

Greiner bio-one, VACUETTE TUBE, 9NC Coagulation Citrate 3.2%, 3.5ml blue cap-black ring, 24 racks of 50, 1200 pcs in total, non ridged, sandwich tube, Ref: 454332, Lot B040404, Expiry 2005-04, Sterile.

FDA Recall Z-1331-04 · Posted 2004-08-10

Recalling FirmGreiner VACUETTE North America
Recall StatusTerminated
Product CodeGIM
Date Initiated2004-07-27
Date Terminated2004-10-29
Product Quantity314 cases (376,800 pieces)

Reason for Recall

Coagulation tubes may not have received the proper fill of citrate solution.

Firm Action

Consignees were notified by letter on 7/28/2004.

Root Cause

Other

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971221GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc. · 1997-05-02

Official Source

View FDA Recall →

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

↑