Class 2 Device Recall International Biophysics Corp FloPump

• Date Initiated by Firm: June 24, 2019
• Create Date: October 30, 2020
• Recall Status: Terminated 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: 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