Resource Optimization & Innovation Recalls 124 Sterile Arthroscopy Surgical Kits
Resource Optimization & Innovation LLC is recalling 124 sterile arthroscopy surgical kits because the equipment glove component may contain splits or holes that compromise sterility.
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 involves a risk-of-harm product (sterile surgical kit) where the defect compromises sterility, 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 124 sterile arthroscopy surgical kits, identified by Item Number 800422 and OR0491. The kits are custom procedure trays containing 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 lots are 15128 and 16654. 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 and consumers should stop using these kits immediately and contact the manufacturer for instructions on return or replacement. Using non-sterile surgical instruments poses a risk of infection to patients.
The recalled product
- Product
- regard Item Number: 800422, Sterile, OR0491 - Arthroscopy Pk - 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 surgi
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 124
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 numbers 15128 and 16654.
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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