Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 199 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a potential breach of sterility in surgical kits, which poses a significant risk of infection or injury during surgery, meeting the criteria for a Severe rating.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 199 sterile open heart surgical kits (Item Number 800410, CV0479) due to a potential sterility issue. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is being issued because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical instruments and accessories intended for use during a surgical procedure.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The specific lot numbers involved are 15134 and 17453. Healthcare facilities should stop using these kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 800410, Sterile, CV0479 - 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
- 199
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 15134 and 17453.
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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