greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in
Summary
The FDA issued a Class II for greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-r by Greiner Bio-One North America, Inc.. Reason: Some of the tubes may be incorrectly labeled..
Details
Source
Device Recall
External ID
Z-1583-2023
Action Date
2023-05-24
Status
Completed
Category
device
Product Description
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in total, Item #456003
Lot/Code Info: Lot #B220533J, Exp. 2023-10-31, UDI Case label (01)39120017576496(17)231031(10)B220533J, UDI Rack label 29120017576499(17)231031(10)B220533J.
Quantity Affected: 36,000 pieces (30 full cases)
Reason for Recall
Some of the tubes may be incorrectly labeled.
Distribution
US Nationwide distribution in the states of WI and GA.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-03-31
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 147 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-1583-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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