OriGen Biomedical Recalls Reinforced Dual Lumen Cannulas Due to Endotoxin Failure
OriGen Biomedical is recalling 106 units of Reinforced Dual Lumen Cannulas because they failed endotoxin testing. The devices were distributed in 25 US states and four foreign countries.
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 is classified as FDA Class II. The hazard involves endotoxin contamination, which is a high-risk pathogen. No illnesses or injuries are reported in the source text, placing the severity at High (3) rather than Severe (4).
Plain-English summary
OriGen Biomedical, Inc. is recalling 106 units of Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO, and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO. The recall was initiated because the catheters failed endotoxin testing. The affected units are identified by UDI 00816203022059 and lot N18687-1.
The devices were distributed nationwide in the United States, specifically in New York, Arkansas, Missouri, North Carolina, Georgia, Louisiana, Colorado, Alabama, Massachusetts, California, Michigan, Texas, Ohio, Maryland, Florida, Tennessee, South Carolina, Oregon, Arizona, Utah, Rhode Island, South Dakota, Pennsylvania, New Mexico, and Connecticut. The products were also distributed in the United Arab Emirates, Kingdom of Saudi Arabia, New Zealand, and Thailand.
Healthcare providers and consumers should stop using the affected devices and contact OriGen Biomedical, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
- Manufacturer
- OriGen Biomedical, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 106
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 (2)
- UDI: 00816203022059
- lot N18687-1
Distribution
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