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U.S. Department of Health and Human Services

Class 2 Device Recall International Biophysics Corp FloPump

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  Class 2 Device Recall International Biophysics Corp FloPump see related information
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/
OriGen Biomedical, Inc.
7000 Burleson Rd Bldg D
Austin TX 78744-3202
For Additional Information Contact Mrs. Kiersten Soderman
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