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greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep… recallZ-0502-2022 · Greiner Bio-One North America, Inc. · initiated Dec 9, 2021

Class II Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Some of the blood collection tubes show clotting due to variation of Lithium Heparin.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0502-2022
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 9, 2021
Recalling firm
Greiner Bio-One North America, Inc.
Quantity
889,200 pcs.
Product code
JKA
FDA submissions
K960857
Distribution
Distribution was made to FL, IL, MO, NC, NM, NY, PA, TN, TX, and VA. There was no foreign/military/government distribution.

Product description

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

Code information (models, lots, serial numbers)

Lot #B21053QG, Exp. 09/09/2022, UDI: Case: 39120017579046, Rack: 29120017579049.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

2 devices cleared under K960857 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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