Recall Z-0184-2019— OriGen Biomedical, Inc.
Class II · Terminated
Class II FDA medical device recall by OriGen Biomedical, Inc., initiated 2018-08-21, terminated 2021-07-15. It names one FDA 510(k) clearance: K113869. Product: Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.. Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip.
- Recalling firm
- OriGen Biomedical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-21
- Terminated
- 2021-07-15
- Firm location
- Austin, TX, United States
510(k) clearances named in this recall
1 on FDA's recordK-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, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion of blood in the internal jugular vein during extracorporeal life support procedures.
Reason for recall
These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Data sourced from openFDA. This site is unofficial and independent of the FDA.