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FDA Medical Device Recalls (openFDA)

C.A. Greiner & Sohne Gesellschaftmbh: 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.

Recall number
Z-2116-2020
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.
Status
Terminated
Initiated
2020-04-03
Posted
not on file
Terminated
2021-07-25
Reason
While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.
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
90,400 pieces.
Distribution
*requested 4/15/2020
Lot, serial or model codes
Item no. 450225. UDI no. 39120017577547 and 29120017577540.
510(k) numbers
not on file
PMA numbers
not on file
Product code
JKA
Firm FEI
6368
Firm city
Kremsmunster
Firm state
not on file
Firm country
Austria

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
3e6df46828c1
Size
288213574 bytes
Published
2026-10-06
Read
2026-10-07T03:20:25.099Z
Source file
Source file retained · verify
Refresh due
2026-10-14

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

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