OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Deficiencies
OriGen Biomedical is recalling 435 Reinforced Dual Lumen Cannulas because they may lack barium sulfate and have tips shorter than labeled.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with potential for significant injury or structural defects are classified as Severe (Score 4).
Plain-English summary
OriGen Biomedical, Inc. is recalling 435 units of the Reinforced Dual Lumen Cannula, 19Fr. (REF: VV19F, Sterile EO). The device 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.
The recall is due to two potential deficiencies: the catheters may have an omission of barium sulfate, and the actual catheter tip length may be one centimeter shorter than what is printed on the tip. The affected lots are N18394, N18447, N18447-1, N18447-1A, P18909, and P18971, with UDI 00816203022097.
The products were distributed nationwide in the United States and to various countries worldwide, including Canada, the EU, and the UK. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of the affected devices.
The recalled product
- Product
- Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, 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 proced
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheters
- Affected units
- 435
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 (7)
- UDI: 00816203022097
- Lot: N18394
- N18447
- N18447-1
- N18447-1A
- P18909
- P18971
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.
See all 6 products in this recall →Related recalls
Same manufacturer · OriGen Biomedical, Inc.
See all →- HighOriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility
FDA (Devices) · 2024-02-21
- ModerateOriGen Evolve Cell Culture Bags Recalled for Incorrect Phthalate Labeling
FDA (Devices) · 2021-04-21
- ModerateOriGen Biomedical Recalls Expired 3/8 FloPump Medical Devices
FDA (Devices) · 2020-11-11
- HighOriGen ECMO Reinforced Dual Lumen Cannula Recalled for Potential Tube Disconnect
FDA (Devices) · 2019-06-12
- HighOriGen ECMO Reinforced Dual Lumen Cannula Recalled for Adhesive Bond Failure
FDA (Devices) · 2019-06-12
Same hazard · material omission
See all →- HighOriGen Biomedical Recalls 13Fr Reinforced Dual Lumen Cannulas
FDA (Devices) · 2018-10-24