Product Wiki · Recalls · U.S. FDA — Device Enforcement

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. 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 cardiovascula

U.S. FDA — Device Enforcement · United States · 2013-03-28 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1147-2013
Date of alert: 2013-03-28
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Transonic Systems Inc
Product category: device
Product type: Devices

Reported risk: Transonic Systems Inc. have received complaints of blood leakage involving the AV Loop Kit.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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