Recall Z-0318-2021— OriGen Biomedical, Inc.

Name: FDA recall Z-0318-2021
Creator: U.S. Food and Drug Administration
Published: 2019-06-24

Class II · Terminated

Class II FDA medical device recall by OriGen Biomedical, Inc., initiated 2019-06-24, terminated 2021-07-14. It names one FDA 510(k) clearance: K170029. Product: 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only. Reason: The firm has become aware that they have distributed product that was expired..

Recalling firm: OriGen Biomedical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-24
Terminated: 2021-07-14
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K170029 — FloPump 32mL, Sterile, FloPump 32mL, Non-SterileInternational Biophysics Corporation·cleared 2017-12-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The firm has become aware that they have distributed product that was expired.

Data sourced from openFDA. This site is unofficial and independent of the FDA.