Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 440 sterile open heart surgical kits because the equipment glove component 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 kit) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 440 sterile open heart surgical kits (Item Number: 800410001, CV0479A). The recall is due to a defect in the equipment glove component, which may contain splits or holes that compromise the sterility of the kit.
The affected kits are custom procedure trays containing surgical instruments and accessories intended for use during surgical procedures. The distribution was made to facilities in Louisiana, Mississippi, and Texas. The affected lot numbers are 20128, 20978, 21157, 22795, 23580, 24104, and 18779.
Healthcare facilities should stop using these kits and contact the recalling firm for instructions on return or replacement. Patients who have already had procedures using these kits should contact their healthcare provider if they have concerns.
The recalled product
- Product
- regard Item Number: 800410001, Sterile, CV0479A - Open Heart 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…
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 440
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 (7)
- Lot numbers 20128
- 20978
- 21157
- 22795
- 23580
- 24104
- and 18779.
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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