FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 80 custom cardiovascular surgical kits because compromised package integrity may affect sterility assurance.
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 is classified as FDA Class II and involves a risk-of-harm product (sterility compromise) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 80 units of the Regard Item Number 830045, CV0443D - CV BUNDLE, a custom surgical kit intended 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 defect potentially affects the sterility assurance of the surgical kit.
The affected products were distributed in Texas and Louisiana. The recall covers specific lot codes: 19215, 19570, 20849, 22557, 23871, 25469, and 27185.
Healthcare facilities and consumers should stop using these kits immediately and contact the recalling firm for instructions on return or disposal. The U.S. Food and Drug Administration has classified this as a Class II recall.
The recalled product
- Product
- Regard, Item Number 830045, CV0443D - CV BUNDLE - Custom surgical kit for cardiovascular surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 80
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 (7)
- 19215
- 19570
- 20849
- 22557
- 23871
- 25469
- and 27185
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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