Resource Optimization & Innovation Recalls Sterile Open Heart Surgical Kits
Resource Optimization & Innovation LLC is recalling 36 sterile Open Heart surgical kits because equipment glove components may contain 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 compromise of sterility.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 36 sterile Open Heart A&B surgical kits (Item Number 880327002, CV0758B). The kits contain surgical instruments and accessories intended for use during a surgical procedure. The recall is due to equipment glove components that may contain splits or holes, which could compromise the sterility of the kits.
The affected lots are 24298 and 24572. Distribution was made to Louisiana, Mississippi, and Texas. The responsible firm on the label is ROi, LLC, St. Louis, MO.
Healthcare facilities and consumers should stop using these kits and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- regard Item Number: 880327002, sterile, CV0758B - Open Heart A&B - 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 s
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 36
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 24298 and 24572.
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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