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

Recall Z-1928-2020 — Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oximetry catheter on the other end to continuously measure venous oxygen saturation.

U.S. FDA — Device Enforcement · United States · 2019-10-07 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1928-2020
Date of alert: 2019-10-07
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Edwards Lifesciences, LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 13710131

Reported risk: Intermittent communication due to inconsistent crimping of connectors onto cables.

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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