Resource Optimization & Innovation LLC Recalls Sterile Extremity Surgical Kits
Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
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: The recall involves a risk-of-harm product (sterile surgical kit) where sterility is compromised, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 672 sterile extremity surgical kits (Item Number 800548, OR0637). These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The recall is due to a defect in the equipment glove component, which may contain splits or holes that compromise the sterility of the kit.
The affected kits are identified by lot numbers 16821 and 18550. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal. Patients who have had procedures using these kits should consult their healthcare provider if they have concerns regarding potential sterility compromise.
The recalled product
- Product
- regard Item Number: 800548, Sterile, OR0637 - Extremity - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 672
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)
- Lot numbers 16821
- and 18550.
Distribution
Part of a larger recall action
This product is one of 77 recalled by Resource Optimization & Innovation Llc 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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