| Date Initiated by Firm |
June 24, 2019 |
| Create Date |
October 30, 2020 |
| Recall Status1 |
Terminated 3 on July 14, 2021 |
| Recall Number |
Z-0318-2021 |
| Recall Event ID |
85124 |
| 510(K)Number |
K170029
|
| Product Classification |
Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
|
| Product |
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only |
| Code Information |
Lot # 042417-5045 |
Recalling Firm/
Manufacturer |
OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
|
| For Additional Information Contact |
Mrs. Kiersten Soderman
512-615-7606
|
Manufacturer Reason
for Recall |
The firm has become aware that they have distributed product that was expired.
|
FDA Determined
Cause 2 |
Nonconforming Material/Component |
| Action |
On 6/24/2019, a email was sent to the affected customer informing them that the product was expired and requesting that it be returned. |
| Quantity in Commerce |
6 units |
| Distribution |
US: TX |
| 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.
|
| 510(K) Database |
510(K)s with Product Code = KFM and Original Applicant = INTERNATIONAL BIOPHYSICS CORPORATION
|
