Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
FDA Recall Z-2507-2021 · Posted None
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Recalling FirmGreiner Bio-One North America, Inc.
Recall StatusTerminated
Product CodeGIM
Date Initiated2021-08-20
Date Terminated2023-10-04
Product Quantity956,400
Reason for Recall
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.
Firm Action
A letter was sent on August 20, 2021 with the following actions:
Necessary actions:
We need your assistance to address this recall. Please perform the following steps.
" Stop using the above-mentioned product (concerned item/lot) immediately and
isolate defective products in your facility.
" Assess risks and consequences for the use of this defective product in
accordance with your procedures and take appropriate action.
" Complete the attached Product Disposition Site Confirmation form and fax to
Greiner Bio-One North America, Inc. at 800.726.0052 or email to [email protected].
This form is to confirm that you have discarded/destroyed all products from these
items/lots. We will replace the product after the completed form is sent to Greiner.
If you have additional questions, please call our Technical Service at 800-515-8112.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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