OriGen Biomedical Recalls Expired 3/8 FloPump Medical Devices
OriGen Biomedical is recalling six units of 3/8-inch FloPump devices distributed in Texas because the products were expired.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves expired medical devices, which fits the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures without reported injuries.
Plain-English summary
OriGen Biomedical, Inc. is recalling six units of 3/8-inch FloPump, 32mL, sterile medical devices. The recall was initiated because the firm became aware that the distributed product was expired.
The affected devices are identified by Lot # 042417-5045 and UDI (01) 081432102013 1. The products were distributed in Texas. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected devices and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
- Manufacturer
- OriGen Biomedical, Inc.
- Hazard
- Affected units
- 6
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 (1)
- Lot # 042417-5045
Distribution
Distributed in 1 state:
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