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Terminated

Greiner bio-one, 4ml K2E EDTA K2 Vacuette tube. Used for venous blood collection. Item number 454209.

FDA Recall Z-0184-2012 · Posted 2011-11-14

Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeJKA
Date Initiated2011-08-12
Date Terminated2012-03-12
Product Quantity504,000 pieces

Reason for Recall

Vacuette 4ml EDTA DK2 tubes have been reported for short fills to no fills.

Firm Action

Consignees were notified by Greiner bio-one letter on August 11, 2011. They were instructed to: Stop distributing the material, complete the product Disposition form attach and to fax it to Greiner bio-one and to destroy or return any of the affected products for replacement or credit. Distributors were asked to provide a list of their customers that have received the item, preferably in an Excel file, so that they could be notified of the recall.

Root Cause

Process control

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K971236GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc. · 1997-05-12

Official Source

View FDA Recall →

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

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