Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ri
Summary
The FDA issued a Class II for Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 bl by Greiner Bio-One North America, Inc.. Reason: Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum..
Details
Source
Device Recall
External ID
Z-2507-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
Lot/Code Info: Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.
Quantity Affected: 956,400
Reason for Recall
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Distribution
US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, IN, KY, LA, MD, ME, MO, MT, NC, NE, NM, NV, NY, OH, OR, PA, TX, VA, WA and Puerto Rico.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-20
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 173 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-2507-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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