Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 416 sterile C-section surgical kits because a glove component 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 involves a risk-of-harm product (sterile surgical kit) where the hazard (compromised sterility) could lead to infection, 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 416 sterile C-section surgical kits, Item Number 800557, Lot numbers 16674, 18157, 19155, 20423, and 23433. The kits are custom procedure trays containing surgical instruments and accessories intended for use during a surgical procedure.
The recall was initiated because the kits contain an equipment glove component which may contain splits or holes that compromise the sterility of the device. The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement. Consumers are not expected to have these products in their homes, as they are intended for professional medical use.
The recalled product
- Product
- regard Item Number: 800557, Sterile, LD0646 - 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
- 416
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 (5)
- Lot numbers 16674
- 18157
- 19155
- 20423
- and 23433.
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
- HighRecall of Sterile C-Section Procedure Kits Due to Glove Splitting Risk
FDA (Devices) · 2017-04-05
- HighResource Optimization Recalls Sterile C-Section Kits Due to Glove Defect
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