Resource Optimization Recalls 28 Custom Cardiovascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 28 custom cardiovascular surgical kits because a component had compromised package integrity, potentially affecting 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 injury has not yet been reported, fitting the High severity criteria for potential sterility compromise.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 28 units of Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART custom surgical kits for cardiovascular surgery. The recall was initiated because the kits contain a component, specifically ORS fluid warming and slush drapes, that was previously recalled due to compromised package integrity. This issue potentially affects the sterility assurance of the surgical kits.
The affected products were distributed in Texas and Louisiana. The recall is classified as Class II by the U.S. Food and Drug Administration. No specific lot numbers or expiration dates are provided in the source text, but the code information is listed as 19345.
Healthcare facilities and consumers who have these specific surgical kits should stop using them immediately and contact the recalling firm for instructions on return or disposal. The primary hazard is the potential loss of sterility, which could lead to infection if the kits are used in a surgical setting.
The recalled product
- Product
- Regard, Item Number 800301001, Sterile, CV0708A - OPEN HEART- Custom surgical kit for cardiovascular surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 28
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)
- 19345
Distribution
Part of a larger recall action
This product is one of 8 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.
See all 8 products in this recall →Related recalls
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