FDA Recalls 230 Sterile C-Section Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 230 sterile C-section 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 involves a risk-of-harm product (sterile surgical kit) where sterility compromise 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
The U.S. Food and Drug Administration (FDA) is recalling 230 units of sterile C-section surgical kits manufactured by Resource Optimization & Innovation LLC. The kits, identified by Item Number 800524001 and Lot numbers 20196, 20647, and 20818, contain 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. These defects may compromise the sterility of the surgical kit, posing a risk of infection to patients during the procedure.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The FDA classifies this as a Class II recall. Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 800524001, Sterile, LD0608A - 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
- 230
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 (3)
- Lot numbers 20196
- 20647
- and 20818.
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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