OriGen Biomedical Accessory Syringe Sets Recalled for Sterilization Incompatibility
OriGen Biomedical is recalling 3,613 cases of accessory syringe sets due to design and material changes that caused loss of gamma sterilization compatibility, resulting in yellowed discoloration and unqualified product status.
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 3/5 (High).
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: This is a Class II medical device recall with no reported illnesses or injuries. The hazard—material degradation from sterilization incompatibility—constitutes a risk-of-harm product without reported injury, meeting the criteria for High severity.
Plain-English summary
OriGen Biomedical, Inc. is recalling 3,613 cases of Accessory Sets Syringes. The recalled products include 6ml syringes with female luer connectors and 15cm sealed tubing (reference RF-T15) and 60ml syringes with female luer connectors and 15cm sealed tubing (reference 15-RF60-T).
The recall was issued because design changes to the syringe barrels and a change in the polypropylene resin formulation resulted in loss of gamma sterilization compatibility. Gamma-sterilized syringes from the affected lots developed visible yellowing. These syringes are not qualified for their intended purpose.
The affected product was distributed in the United States (Florida, Washington, New Jersey, Massachusetts, Ohio, California, Maryland, Texas, Nebraska, North Dakota) and internationally (United Kingdom, Canada, Netherlands, Switzerland, Poland, Germany).
Further information regarding this recall should be obtained from OriGen Biomedical, Inc.
The recalled product
- Product
- Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-T
- Manufacturer
- OriGen Biomedical, Inc.
- Affected units
- 3,613
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 (4)
- REF/UDI-DI/Lots: RF-T15/10816203020205/ V23277
- V23278
- V23639
- 15-RF60-T/10816203020571/V23281
Distribution
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