Z-0318-2021Class II

3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only

Name: Z-0318-2021 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Creator: OriGen Biomedical, Inc.
Published: 2019-06-24
License: https://open.fda.gov/license/

OriGen Biomedical, Inc. / initiated 2019-06-24 / Terminated / root cause: manufacturing process

FDA source

OriGen Biomedical, Inc. began a recall of 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only on 2019-06-24. FDA classified it as Class II and gives the reason as "The firm has become aware that they have distributed product that was expired". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0318-2021
Classification: Class II
Status: Terminated
Initiated: 2019-06-24
Posted: 2020-10-30
Terminated: 2021-07-14
Recalling firm: OriGen Biomedical, Inc.
Product: 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Product code: KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Reason for recall: The firm has become aware that they have distributed product that was expired.
Root cause tag: manufacturing process
FDA root 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
Product codes and lots: Lot # 042417-5045

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0318-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0318-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-10-30

Product code KFM

K170029Class IIFloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation / cleared 2017-12-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)