OriGen Biomedical Recalls 13Fr Reinforced Dual Lumen Cannulas
OriGen Biomedical is recalling 1,517 units of 13Fr Reinforced Dual Lumen Cannulas due to missing barium sulfate and inaccurate tip length markings.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device used in extracorporeal life support with a structural defect (tip length discrepancy) and material omission (barium sulfate), representing a risk-of-harm product where specific injury reports are not detailed in the source text.
Plain-English summary
OriGen Biomedical, Inc. is recalling 1,517 units of Reinforced Dual Lumen Cannulas and ECMO Reinforced Dual Lumen Cannulas, 13Fr. (REF: VV13F, Sterile EO). The affected 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 deficiencies including the omission of barium sulfate and actual catheter tip lengths that are one centimeter shorter than printed on the tip. The affected lots include N18687, N18687-1, R19506, S19746, S19760, S19761, S19772, S19781, S19880, N18549, and N18573.
The devices were distributed worldwide, including nationwide in the United States and in numerous international countries such as Canada, the United Kingdom, Germany, and Japan. Healthcare providers and facilities should stop using the affected devices and contact OriGen Biomedical for further instructions.
The recalled product
- Product
- Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, 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
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 1,517
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 (12)
- UDI: 00816203022059
- Lot: N18687
- N18687-1
- R19506
- S19746
- S19760
- S19761
- S19772
- S19781
- S19880
- N18549
- N18573
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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