FDA Medical Device Recalls (openFDA)
Greiner Bio-One North America, Inc.: greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
- Recall number
- Z-0502-2022
- Recalling firm
- Greiner Bio-One North America, Inc.
- Product
- greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs., 1200 pcs. in total, REF 456087P
- Status
- Terminated
- Initiated
- 2021-12-09
- Posted
- not on file
- Terminated
- 2023-10-10
- Reason
- Some of the blood collection tubes show clotting due to variation of Lithium Heparin.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm initiated issuance of recall letters dated 12/9/2021 on the same date via email, phone, USPS, or UPS to their end-user customers. The letter explains the issue, the potential health hazard, and the necessary actions to be taken. The actions included to discontinue use of the affected product and isolate the products in their facility; assess risks and consequences for the use of the defective product in accordance with the consignee's procedures and take the appropriate action; and complete the attached Product Disposition Site Confirmation form and FAX it to the recalling firm. The form is a confirmation that the affected product has been discarded/destroyed. The product will be replaced by the recalling firm. The Customer Disposition form says if they have further distributed the product, they should provide the customer contact information to the recalling firm so that further follow-up can be made. For distributors. the letters were issued on 12/10/2021 via email. The email requests the distributor to provide a list of their customers to the recalling firm for further follow-up or to perform a subrecall themselves to the end-user customers. The distributor recall letter describes the problem and instructs the distributor to stop distributing the product and isolate it. A Product Disposition form was enclosed for completion to be returned via FAX or email. The recalling firm would then contact the distributor as to return or destruction for the product. The letter also informs the distributor it is a legal obligation to notify customers, therefore, they are requested to provide a list of their customers who have received the affected product, even though the cover email gives them the option of contacting the customers themselves.
- Quantity
- 889,200 pcs.
- Distribution
- Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.
- 510(k) numbers
- ["K960857"]
- PMA numbers
- not on file
- Product code
- JKA
- 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