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

Recall Z-2133-2019 — Nasal Alar SpO2 Sensor, Adult/Pediatric SpO2 Sensor, Rx Only Product Usage: The Assurance¿ Nasal Alar SpO2 Sensor is indicated for single patient use for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate from the nasal ala of adult an

U.S. FDA — Device Enforcement · United States · 2019-05-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2133-2019
Date of alert: 2019-05-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Xhale Assurance, Inc.
Product category: device
Product type: Devices

Reported risk: These Instructions for Use has missing instructions related to the checking and changing of the application site procedure.

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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