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

Recall Z-0156-2015 — Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to delive

U.S. FDA — Device Enforcement · United States · 2011-03-01 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0156-2015
Date of alert: 2011-03-01
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Terumo Cardiovascular Systems Corp
Product category: device
Product type: Devices

Reported risk: Defect in the luer connector can compromise the seal on the female side of the connector and the compromised seal can introduce air in the table line

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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