Resource Optimization & Innovation LLC Recalls Pediatric Cardiac Catheterization Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 pediatric cardiac catheterization 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 sterile medical device where compromised sterility poses a risk of infection (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 24 units of Item Number 800555, Sterile, HT0644 - Pediatric Card Cath - surgical kits. These custom procedure trays contain surgical instruments and accessories intended for use during a surgical procedure. The recall is due to a defect where the equipment glove component may contain splits or holes, which compromises the sterility of the kit.
The affected kits are identified by Lot number 17439. Distribution was made to facilities in Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, located in St. Louis, MO.
Healthcare facilities should stop using these kits and contact the manufacturer for instructions on return or replacement. Patients who have already received these kits should consult their healthcare provider regarding potential risks associated with compromised sterility.
The recalled product
- Product
- regard Item Number: 800555, Sterile, HT0644 - Pediatric Card Cath - 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
- 24
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 number 17439.
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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