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

Recall Z-0434-2013 — SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign Membrane Changer Insert is indicated for use with the V-Sign Membrane Changer only. The V-sign Sensor is indicated for use with the SenTec Digital Monitor when continuous non-invasive monitoring of carbon dioxide tension

U.S. FDA — Device Enforcement · Switzerland · 2012-11-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0434-2013
Date of alert: 2012-11-05
Country / jurisdiction: Switzerland
Risk level: Class II
Risk type: recall
Brand: Sentec AG
Product category: device
Product type: Devices

Reported risk: A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

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

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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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