FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-2507-2021
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- Greiner Bio-One VACUETTE TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged
- Status
- Terminated
- Initiated
- 2021-08-20
- Posted
- not on file
- Terminated
- 2023-10-04
- 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 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.
- 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.
- Lot, serial or model codes
- Lot # B210533B Expiration 05/10/22 and B210439J Expiration 04/13/2022.
- 510(k) numbers
- ["K971221"]
- PMA numbers
- not on file
- Product code
- GIM
- Firm FEI
- 3001451379
- Firm city
- Monroe
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28