Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cardiac Insulation Pad Recalled by Medline Industries, Inc. Due to Complete delivery System (CDS) # CDS984746C was assembled...
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 Medline Industries, Inc. directly.
Affected Products
Cardiac Insulation Pad, OPEN HEART CDS
Quantity: 77 kits
Why Was This Recalled?
Complete delivery System (CDS) # CDS984746C was assembled using a non-sterile cardiac insulation pad, Medline component number 32369. The non-sterile component (32369) was placed within the non-sterile portion of the CDS assembly. This component should have been placed inside the sterile portion of the pack where it would have subsequently been exposed to an ethylene oxide sterilization process. This component was not placed in the sterile portion of the pack and was not sterilized, resulting in the inadvertent release of this item in a non-sterile state. The contents of the sterile kit were properly sterilized and the remaining contents of the non-sterile subassembly had the appropriate sterility status based on their intended use.
Where Was This Sold?
This product was distributed to 2 states: CA, NM
About Medline Industries, Inc.
Medline Industries, Inc. has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report