Recall Z-0102-2019— OriGen Biomedical, Inc.

Name: FDA recall Z-0102-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-21

Class II · Terminated

Class II FDA medical device recall by OriGen Biomedical, Inc., initiated 2018-08-21, terminated 2021-10-05. It names one FDA 510(k) clearance: K113869. Product: Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO. Reason: The catheter failed the endotoxin testing..

Recalling firm: OriGen Biomedical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-08-21
Terminated: 2021-10-05
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K113869 — ORIGEN REINFORCED DUAL LUMEN CATHETEROrigen Biomedical, Inc.·cleared 2012-07-26

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

Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO

Reason for recall

The catheter failed the endotoxin testing.

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