HCS3011 AV Loop Kit For use with Transonic CO status System Only — Class II medical device recall Z-1147-2013
Terminated recall by Transonic Systems Inc, reported 2013-04-24, distributed nationwide. Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
| Recall number | Z-1147-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Transonic Systems Inc, Ithaca, NY, United States |
| Recall initiated | 2013-03-28 |
| Classified | 2013-04-18 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2014-03-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, NL, RU |
| Reason classes | packaging |
| Lot numbers | 010311, 102810, 111810 |
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 for recall
Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1147-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.