Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Regard Recalled by Resource Optimization & Innovation Llc Due to Custom surgical kits contain a component (ORS fluid...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Resource Optimization & Innovation Llc directly.
Affected Products
Regard, Item Number 830054002, CV00625B - OPEN HEART A&B - Custom surgical kit for cardiovascular surgery.
Quantity: 77 kits
Why Was This Recalled?
Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
Where Was This Sold?
Distributed in Texas and Louisiana.
About Resource Optimization & Innovation Llc
Resource Optimization & Innovation Llc has 224 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report