Z-2116-2020Class II

VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 -

Name: Z-2116-2020 VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 -
Creator: C.A. Greiner & Sohne Gesellschaftmbh
Published: 2020-04-03
License: https://open.fda.gov/license/

C.A. Greiner & Sohne Gesellschaftmbh / initiated 2020-04-03 / Terminated

FDA source

C.A. Greiner & Sohne Gesellschaftmbh began a recall of VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe... on 2020-04-03. FDA classified it as Class II and gives the reason as "While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2116-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-03
Posted: 2020-05-26
Terminated: 2021-07-25
Recalling firm: C.A. Greiner & Sohne Gesellschaftmbh
Product: VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration date: 2022-02-07 - Product Usage: The Blood Transfer Unit is used to transfer blood from a syringe into the evacuated blood collection tube.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.
FDA root cause: Under Investigation by firm
Action: Greiner BIO-ONE notified customers on 04/03/2020 via "Urgent Product Recall-VACUETTE Blood Transfer Unit" letter. The recall letter identified the affected product and lot numbers. The firm requested the customers to immediately isolate the defective product and complete the product disposition form.
Quantity in commerce: 90,400 pieces.
Distribution: *requested 4/15/2020
Product codes and lots: Item no. 450225. UDI no. 39120017577547 and 29120017577540.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2116-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2116-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-26

Product code JKA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)