Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
HCS3011 AV Loop Kit For use with Transonic CO status System Only Recalled by Transonic Systems Inc Due to Transonic Systems Inc. have received complaints of blood...
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 Transonic Systems Inc directly.
Affected Products
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only. Product Usage: is indicated for use in patients greater than or equal to 2 years old with arterial and venous lines in the diagnostic assessment of cardiovascular status including cardiac output and associated hemodynamic parameters.
Quantity: 195 units total (140 units Domestic, 55 units Foreign)
Why Was This Recalled?
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Transonic Systems Inc
Transonic Systems Inc has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report