VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Summary
The FDA issued a Class II for VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged by Greiner Bio-One North America, Inc.. Reason: Blood collection tubes may experience a clotting issue..
Details
Source
Device Recall
External ID
Z-2485-2021
Action Date
2021-10-06
Status
Terminated
Category
device
Product Description
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged
Lot/Code Info: Item Number 456279, Lot B21033DA, exp. 09/08/2022, UDI Case - 39120017571248; UDI Rack - 29120017571241 UPDATE per 9/10/2021 email: Item Number 456279, Lot B21053R8, exp. 11/10/2022, UDI Case -39120017571248; UDI Rack - 29120017571241.
Quantity Affected: 962,400 tubes
Reason for Recall
Blood collection tubes may experience a clotting issue.
Distribution
Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA, TX, and VA. Foreign distribution was made to Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-13
Company
Monroe, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 201 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Greiner Bio-One North America, Inc. has 9 FDA actions in our database, including 8 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Greiner Bio-One North America, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Greiner Bio-One North America, Inc. have FDA actions?
Greiner Bio-One North America, Inc. has 9 FDA actions in our database, including 8 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2485-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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