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

Recall Z-0057-2017 — The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

U.S. FDA — Device Enforcement · United States · 2016-07-01 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0057-2017
Date of alert: 2016-07-01
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Circulatory Technology Inc
Product category: device
Product type: Devices

Reported risk: Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.

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.

Recall Z-0057-2017 — The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the extracorporeal circuit and provide compliance in the venous line between the patient and the pump.

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