Resource Optimization & Innovation Recalls Sterile C-Section Surgical Kits
Resource Optimization & Innovation LLC is recalling 600 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 kits) where sterility is compromised, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for theoretical risk without reported harm.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 600 sterile C-section surgical kits (Item Number 800408, LD0477). The recall was initiated because the kits contain an equipment glove component which may contain splits or holes, potentially compromising the sterility of the surgical instruments and accessories.
The affected lots are 15003 and 17187. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The kits are custom procedure trays intended for use during surgical procedures.
Healthcare facilities should stop using the affected kits and contact the recalling firm for further instructions.
The recalled product
- Product
- regard Item Number: 800408, Sterile, LD0477 - C-Section 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 surgical
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 600
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 15003 and 17187.
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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