Class II — Transonic Systems Inc
| Recalling firm | TRANSONIC SYSTEMS, INC. |
|---|---|
| Registered facility | TRANSONIC SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit. |
| Product | 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) |
| Distribution | Worldwide Distribution - USA Nationwide including the states of AZ, CA, FL, GA, NM, NY, TX, VA and WA and countries of Netherlands, Canada and Russia. |
| Initiated | 2013-03-28 |
| Classified | 2013-04-18 |
| Terminated | 2014-03-05 |
| Recall number | Z-1147-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Transonic Systems Inc (Z-1147-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64770/
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