Resource Optimization & Innovation Recalls 872 Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 872 sterile surgical kits because a glove component may have 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 kits) 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 872 sterile surgical kits, identified by Item Number 800558 and described as OR0647 - Extremity - surgical kits. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The recall is due to a defect in an equipment glove component, which may contain splits or holes that compromise the sterility of the kits.
The affected lots are 17699, 19156, 19846, 20237, 20821, and 24132. Distribution of these kits was made to locations 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 Resource Optimization & Innovation LLC for instructions on return or replacement. Using sterile surgical kits with compromised sterility can increase the risk of infection during surgical procedures.
The recalled product
- Product
- regard Item Number: 800558, Sterile, OR0647 - 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 pr
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 872
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 (6)
- Lot numbers 17699
- 19156
- 19846
- 20237
- 20821
- and 24132.
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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