Smiths Medical Recalls Irrisept OR Bottle Assemblies Due to Sterility Risk
Smiths Medical is recalling 10,440 Irrisept OR bottle assemblies because leaking containers may compromise sterility, posing an infection risk.
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 recall is classified as FDA Class II and involves a risk of exposure to infectious agents, which aligns with the rubric criteria for Severe severity involving significant injury risk or hospitalization potential.
Plain-English summary
Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company, is recalling 10,440 units of the Irrisept OR, Finished Bottle Assembly 450 ml STEP 1. The recall is due to a lack of sterility assurance, as leaking containers could lead to exposure to infectious agents.
The affected product is identified by Model # FB-A-400-107 and Lot Number 4J006. The units were distributed to facilities in Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, and Wisconsin.
Healthcare facilities should stop using the affected product and contact the manufacturer for instructions on return or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Irrisept OR, Finished Bottle Assembly 450 ml STEP 1
- Affected units
- 10,440
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)
- Model # FB-A-400-107 Lot Number: 4J006
Distribution
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