Class II — OriGen Biomedical, Inc.
| Recalling firm | ORIGEN BIOMEDICAL, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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 |
| Product | Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, 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. |
| Quantity | 452 |
| Distribution | Worldwide Distribution: U.S.(nationwide) to states of: IN, NY, CA, MA, TX, OH, KY, MI, MS, NM, NC, VA, WI, TN, CT, FL, AR, MO, GA, LA, DC, OR, MN, SC, OK, AZ, UT, RI, SD, WA, PA, AL, MD, IL, HI; and countries (OUS) of: Argentina, Austria, Belgium, CANADA, Colombia, EU, Germany, India, Italy, Japan, Kingdom of Saudi Arabia, Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, SWEDEN, Th… |
| Initiated | 2018-08-21 |
| Classified | 2018-10-18 |
| Terminated | 2021-07-15 |
| Recall number | Z-0180-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OriGen Biomedical, Inc. (Z-0180-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80930/
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