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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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…
- 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.
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