ClearanceBrief
Recall Z-2116-2020 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

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.

DateApr 3, 2020
StatusTerminated
ReasonWhile transferring blood the needle may dislodged and remain in the tube stopper which may cause needle stick injury or blood leakage.
Root causeUnder Investigation by firm
ActionGreiner 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.
Quantity90,400 pieces.
Distribution*requested 4/15/2020
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.