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Recall Observatory FDA recall evidence

Device 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.

Z-2116-2020

April 03, 2020

Class II

Product summary

Firm
C.A. Greiner & Sohne Gesellschaftmbh
Event
Event 85411
Status
Terminated
Classification
Class II
Quantity
90,400 pieces.
Official record key
device-enforcement:Z-2116-2020

Official wording

Reason: While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.

Code information: Item no. 450225. UDI no. 39120017577547 and 29120017577540.

Distribution pattern: *requested 4/15/2020

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    While transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.