Resource Optimization & Innovation Recalls Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 500 sterile vascular surgical kits because the equipment glove component may contain 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 sterile medical device where a defect (splits/holes in the glove component) compromises sterility, creating a risk of infection. No illnesses or injuries are reported in the source text, and the agency classification is Class II, which aligns with a High severity rating for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 500 sterile vascular surgical kits (Item Number 800413001, CV0482A). The kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures. The recall was initiated because the kits contain an equipment glove component which may contain splits or holes, potentially compromising the sterility of the device.
The affected lots are 19412, 19858, 22464, 23253, and 24066. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement. Patients who have had procedures using these kits should consult their healthcare provider if they have concerns about potential sterility compromise.
The recalled product
- Product
- regard Item Number: 800413001, Sterile, CV0482A - Vascular 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 surgi
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 500
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 19412
- 19858
- 22464
- 23253
- and 24066.
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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