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VACUETTE Blood Transfer Unit. Lot no. A19024NX. Expiration… recallZ-2116-2020 · C.A. Greiner & Sohne Gesellschaftmbh · initiated Apr 3, 2020

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 C.A. Greiner & Sohne Gesellschaftmbh 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

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 category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-2116-2020
Status
Terminated
Initiated by the company
Apr 3, 2020
Recalling firm
C.A. Greiner & Sohne Gesellschaftmbh
Quantity
90,400 pieces.
Product code
JKA
Distribution
*requested 4/15/2020

Product description

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.

Code information (models, lots, serial numbers)

Item no. 450225. UDI no. 39120017577547 and 29120017577540.

Devices named in this recall

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

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page