Recall Z-2507-2021 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner Bio-One North America, Inc.
Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
| Date | Aug 20, 2021 |
| Status | Terminated |
| Reason | Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. |
| Root cause | Under Investigation by 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 patech@gbo.com. This form is to |
| Quantity | 956,400 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 2, 1997 |