OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies
OriGen Biomedical is recalling 452 units of Reinforced Dual Lumen Cannulas due to missing barium sulfate and incorrect tip length markings.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity score.
Plain-English summary
OriGen Biomedical, Inc. is recalling 452 units of Reinforced Dual Lumen Cannulas, 16Fr. (REF: VV16F, Sterile EO). The affected lots are N18404, N18446, N18640, N18640-1, and R19208. These medical devices are 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.
The recall was initiated because the catheters may have two specific deficiencies: the omission of barium sulfate and an actual catheter tip length that is one centimeter shorter than what is printed on the tip. The omission of barium sulfate may affect the radiopacity of the device, while the discrepancy in tip length may impact clinical placement accuracy.
The affected products were distributed nationwide in the United States to numerous states, including 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, and HI. Additionally, the products were distributed internationally to countries including Argentina, Austria, Belgium, Canada, Colombia, the EU, Germany, India, Italy, Japan, the Kingdom of Saudi Arabia, the Netherlands, New Zealand, Poland, Qatar, Romania, South Africa, Sweden, Thailand, the UK, the United Arab Emirates, and Vietnam. Healthcare providers should stop using the affected units and contact the manufacturer for instructions.
The recalled product
- 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 procedu
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 452
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- UDI 00816203022073
- Lot: N18404
- N18446
- N18640
- N18640-1
- R19208
Distribution
Part of a larger recall action
This product is one of 6 recalled by OriGen Biomedical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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