Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component 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 is compromised, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits (Item Number 800413, CV0482). 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 product.
The affected lots are 15019 and 17537. 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 received care using these kits should consult their healthcare provider if they have concerns regarding infection or sterility.
The recalled product
- Product
- regard Item Number: 800413, Sterile, CV0482 - 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 surgical
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 288
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 15019 and 17537.
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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