Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components 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 is classified as FDA Class II and involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits, identified by Item Number 800091001 and labeled as LD0692A - C Section. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The specific hazard is that the kits contain an equipment glove component which may have splits or holes, potentially compromising the sterility of the kit.
The affected lots are 19386, 20199, 21696, 22303, 22800, and 23232. Distribution of these kits was made to facilities in Louisiana, Mississippi, and Texas. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have these specific kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. Do not use the kits if the equipment glove component is damaged or if sterility is in question.
The recalled product
- Product
- regard Item Number: 800091001, Sterile, LD0692A - C Section - 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
- 68
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 19386
- 20199
- 21696
- 22303
- 22800
- and 23232.
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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