Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.
What this means for you
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, fitting the 'High' severity criteria for potential sterility compromise.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits (Item Number 880330, OR0761) due to a potential sterility issue. The kits contain an equipment glove component that may have splits or holes, which could compromise the sterile status of the surgical instruments and accessories.
The affected kits were distributed to facilities in Louisiana, Mississippi, and Texas. The recall involves lot numbers 20409 and 21614. These custom procedure trays are intended for use during total hip surgical procedures.
Healthcare facilities should stop using the affected kits and contact the recalling firm for instructions on return or disposal. Patients who have already had surgery using these kits should contact their healthcare provider if they have concerns about infection or other complications.
The recalled product
- Product
- regard Item Number: 880330, Sterile, OR0761 - Total Hip - 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 surgical pr
- 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 numbers 20409 and 21614.
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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