Resource Optimization Recalls Custom Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 10 custom surgical kits distributed in Texas and Louisiana because compromised package integrity may affect 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility assurance in surgical contexts where the risk of infection is significant.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 10 units of Regard Custom Surgical Kits (Item Number 800500002, Sterile, CV0578B - CV PACK). The recall is due to a component, specifically ORS fluid warming and slush drapes, that was previously recalled because compromised package integrity potentially affects sterility assurance.
The affected kits were distributed in Texas and Louisiana. The recall is classified as Class II by the FDA, indicating 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.
Healthcare providers and consumers who have these specific kits should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Regard, Item Number 800500002, Sterile, CV0578B - CV PACK- Custom surgical kit for surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 10
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)
- 24634
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.
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