FDA Device recall Z-1147-2013
HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only
- FDA Device
- Class II
- terminated
- Published 2013-04-24
On 2013-04-24 the FDA classified a Class II recall of HCS3011 AV Loop Kit For use with Transonic CO status System Only, -HCS3021 AV Loop Kit For use with Transonic CO status System Only by Transonic Systems, citing transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1147-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-28 |
| Published | 2013-04-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Transonic Systems |
| Distribution | US |
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.
Reason
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Identifiers
| code_info | Lot numbers: 102810, 010311 and 111810. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1147-2013%22
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