Resource Optimization & Innovation Recalls 874 Sterile Surgical Kits
Resource Optimization & Innovation LLC is recalling 874 sterile surgical kits because a glove component may have 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 the defect (compromised sterility) poses a significant risk of infection, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 874 sterile surgical kits, identified as Item Number 800414, OR0483 - Total Joint Pk. These custom procedure trays contain surgical instruments and accessories intended for use during surgical procedures. The affected lots are 14978, 17321, 18257, 19550, 21698, 22034, 22838, and 24308.
The recall was initiated because the kits contain an equipment glove component which may contain splits or holes. These defects may compromise the sterility of the surgical kit. The distribution of these products was made to facilities in Louisiana, Mississippi, and Texas.
Healthcare facilities should stop using the affected kits and contact the manufacturer for instructions on return or replacement. Patients who have had procedures using these specific kits should contact their healthcare provider if they have concerns regarding the sterility of the instruments used.
The recalled product
- Product
- regard Item Number: 800414, Sterile, OR0483 - Total Joint 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
- 874
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 (8)
- Lot numbers 14978
- 17321
- 18257
- 19550
- 21698
- 22034
- 22838
- and 24308
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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