Z-2116-2020 Class II Terminated
FDA device recall Z-2116-2020 was initiated by C.A. Greiner & Sohne Gesellschaftmbh on April 3, 2020 and is designated Class II. 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. The recall status is terminated (terminated July 25, 2021). Affected quantity: 90,400 pieces..
Recall Details
- Product Type
- Devices
- Report Date
- June 3, 2020
- Initiation Date
- April 3, 2020
- Termination Date
- July 25, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 90,400 pieces.
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.
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.
Distribution Pattern
*requested 4/15/2020
Code Information
Item no. 450225. UDI no. 39120017577547 and 29120017577540.