Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 144 sterile C-section surgical kits because equipment glove components may contain 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 involves a risk-of-harm product (sterile surgical kit) where injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 144 sterile C-section surgical kits (Item Number 800524, Lot numbers 16707 and 18924). The kits contain an equipment glove component which may contain splits or holes that compromise the sterility of the product.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- regard Item Number: 800524, Sterile, LD0608 - 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
- 144
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 16707 and 18924.
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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Similar recalls
- HighResource Optimization Recalls Sterile C-Section Kits Due to Glove Defect
FDA (Devices) · 2017-04-05
- HighRecall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighFDA Recalls Sterile C-Section Procedure Kits Due to Glove Splitting Risk
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- SevereResource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
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- HighRecall of Regard Sterile C Section Packs Due to Glove Splitting Risk
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- HighRecall of Regard Sterile C Section Packs Due to Glove Splitting
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