Recall Z-0818-2020— Greiner Bio-One North America, Inc.

Name: FDA recall Z-0818-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-25

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2019-11-25, terminated 2020-10-05. It names one FDA 510(k) clearance: K983952. Product: VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.. Reason: The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-11-25
Terminated: 2020-10-05
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K983952 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner Meditech, Inc.·cleared 1998-12-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the clinical laboratory.

Reason for recall

The Vacuette 3.5mL Serup Sep Clot Activator Tubes may have been damaged at the cap sealing area. This may lead to a vacuum loss and tubes not filling up to the proper volume.

Data sourced from openFDA. This site is unofficial and independent of the FDA.