| Date Initiated by Firm |
April 03, 2020 |
| Create Date |
May 26, 2020 |
| Recall Status1 |
Terminated 3 on July 25, 2021 |
| Recall Number |
Z-2116-2020 |
| Recall Event ID |
85411 |
| Product Classification |
Tubes, vials, systems, serum separators, blood collection - Product Code JKA
|
| 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. |
| Code Information |
Item no. 450225. UDI no. 39120017577547 and 29120017577540. |
Recalling Firm/
Manufacturer |
C.A. Greiner & Sohne Gesellschaftmbh
Greiner St. #70
Kremsmunster Austria
|
Manufacturer 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.
|
FDA Determined
Cause 2 |
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 in Commerce |
90,400 pieces. |
| Distribution |
*requested 4/15/2020 |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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