FDA Recalls 214 Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 214 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 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 the defect compromises the sterility of surgical kits, which presents a significant risk of serious injury or infection to patients.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 214 sterile neuro surgical kits manufactured by Resource Optimization & Innovation LLC. The affected products are identified by Item Number 800411002, Lot number 24411, and are described as custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures.
The recall was initiated because the kits contain an equipment glove component that may have splits or holes. These defects may compromise the sterility of the surgical kit, posing a risk of infection to patients during use. The distribution of these kits was limited to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities and consumers who possess these specific sterile neuro surgical kits should stop using them immediately. The responsible firm, Resource Optimization & Innovation LLC, is handling the recall. Users should contact the firm for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- regard Item Number: 800411002, Sterile, NU0480B - 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
- 214
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 number 24411.
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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