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U.S. Department of Health and Human Services

Class 2 Device Recall VACUETTE TUBE

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  Class 2 Device Recall VACUETTE TUBE see related information
Date Initiated by Firm November 25, 2019
Create Date January 17, 2020
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-0818-2020
Recall Event ID 84536
510(K)Number K983952  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
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.
Code Information DI: 29120049204476, Lot number B190338E
Recalling Firm/
Manufacturer		 Greiner Bio-One North America, Inc.
4238 Capital Dr
Monroe NC 28110-7681
For Additional Information Contact Kevin Daugherty
704-261-7800
Manufacturer 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.
FDA Determined
Cause 2		 Process control
Action The firm initiated the recall by email on 11/25/2019. The letter explained the problem and requested the consignees cease distribution and provide a list of their customers for Greiner to contact. The firm is seeking return or on site destruction of the affected product.
Quantity in Commerce 1,002,000 tubes
Distribution Nationwide distribution in the states of IL, MO, AZ, NC. PA, UT, NY, ME, PR, VA, PA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = GREINER MEDITECH, INC.
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