FDA Recalls 510 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 510 sterile neuro surgical kits because equipment glove components may have 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 is classified as FDA Class II, and the hazard involves a risk of harm (infection) from compromised sterility in a medical device, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 510 sterile neuro surgical kits manufactured by Resource Optimization & Innovation LLC. The affected products are identified by Item Number 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures.
The recall is being conducted because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical kit, posing a risk of infection to patients during use.
The affected lots are 20112 and 23060. Distribution was made to facilities in Louisiana (LA), Mississippi (MS), and Texas (TX). Healthcare facilities should stop using these kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- regard Item Number: 800411001, Sterile, NU0480A - Neuro 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 510
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 20112 and 23060.
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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