| Class 2 Device Recall VACUETTE TUBE | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JKA
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