FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 77 custom cardiovascular surgical kits because a component's compromised packaging may affect sterility assurance.
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 is classified as FDA Class II and involves a risk-of-harm product (sterility compromise in surgical kits) 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 77 units of the Regard Item Number 830054002, CV00625B - OPEN HEART A&B custom surgical kit for cardiovascular surgery. The recall was initiated because the kits contain a component, specifically ORS fluid warming and slush drapes, that was recalled due to compromised package integrity. This packaging issue potentially affects the sterility assurance of the product.
The affected kits were distributed in Texas and Louisiana. The recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare facilities and consumers who have these specific kits should stop using them immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their medical device supplier for further guidance on how to handle the affected inventory.
The recalled product
- Product
- Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 77
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)
- 24641
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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