Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
OPEN HEART ADULT - SIDE A Recalled by American Contract Systems Inc Due to ACS is unable to confirm product sterilization assurance...
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 American Contract Systems Inc directly.
Affected Products
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Quantity: 90 kits
Why Was This Recalled?
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About American Contract Systems Inc
American Contract Systems Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report