FDA Recall Terminated

Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Recall: Z-2507-2021 · Initiated August 20, 2021

Recall

Recall Number
Z-2507-2021
Event Number
88563
Firm
Greiner Bio-One North America, Inc.
FEI Number
3001451379
Product Code
GIM
Status
Terminated
Root Cause
Under Investigation by firm
Initiated
August 20, 2021
Terminated
October 4, 2023
Address
4238 Capital Dr, Monroe, NC, 28110-7681

Description

Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged

Reason

Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum.

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.

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.

Quantity

956,400