FDA Recalls Custom Cardiovascular Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 153 custom cardiovascular surgical kits because compromised package integrity 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 the hazard involves a potential loss of sterility assurance in surgical kits, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Resource Optimization & Innovation LLC is recalling 153 units of the Regard Custom Surgical Kit for Cardiovascular Surgery (Item Number 830054001, CV00625A - OPEN HEART A&B). The recall is due to a component, specifically ORS fluid warming and slush drapes, that was previously recalled because of compromised package integrity. This issue potentially affects the sterility assurance of the kits.
The affected kits were distributed in Texas and Louisiana. The specific lot codes involved are 22404, 23406, 23642, and 24032. The FDA has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the kits are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action are provided in the source text beyond the general recall notice.
The recalled product
- Product
- Regard, Item Number 830054001, CV00625A - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
- Manufacturer
- Resource Optimization & Innovation Llc
- Category
- Medical Device — Surgical Kits
- Affected units
- 153
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 (4)
- 22404
- 23406
- 23642
- and 24032
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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