Resource Optimization & Innovation Recalls Sterile AV Access Surgical Kits
Resource Optimization & Innovation LLC is recalling 192 sterile AV Access 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 is classified as FDA Class II. The hazard involves compromised sterility in a surgical kit, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 192 sterile AV Access surgical kits (Item Number: 800425, CV0494). 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, potentially compromising the sterility of the device.
The affected lots are 16408 and 18658. Distribution was made to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, Missouri.
Healthcare facilities and consumers should stop using the affected kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 800425, Sterile, CV0494 - AV Access Pk -Spohn 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 sur
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 192
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 16408 and 18658.
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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