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Terminated

Greiner bio-one * Vacuette Tube * 9C Coagulation Sodium, Citrate 3.2%, * 3.5mL * blue cap-black ring * 24 racks of 50, 1200 pcs in total * non-ridged * Sandwich Tube * 454332 * B050609 * 2007-05 * Sterile * manufactured by: Greiner Bio-one North America, Inc., 4238 Capital Drive, Monroe, NC 28110, USA

FDA Recall Z-1498-06 · Posted 2006-09-13

Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeGIM
Date Initiated2006-08-02
Date Terminated2007-01-11
Product Quantity160 cases (192000 pieces)

Reason for Recall

Coagulation tubes found with no additive.

Firm Action

Consignees were notified by letter via fax starting 08/02/2006.

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.

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