Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 54 sterile open heart surgical kits because equipment glove components may contain splits or holes that compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 injury has not yet been reported, which aligns with the High severity criteria in the rubric.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 54 sterile open heart surgical kits (Item Number 880327, CV0758 - Open Heart A&B). The kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures.
The recall is being conducted because the kits contain an equipment glove component which may contain splits or holes that compromise the sterility of the product. The affected lot numbers are 21234 and 23256.
Distribution of the affected kits was made to Louisiana, Mississippi, and Texas. Healthcare facilities and consumers should stop using these kits and contact the recalling firm for further instructions.
The recalled product
- Product
- regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 54
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 21234 and 23256.
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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