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

Recall Z-0895-2015 — Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes

U.S. FDA — Device Enforcement · United States · 2014-11-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0895-2015
Date of alert: 2014-11-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Atricure Inc
Product category: device
Product type: Devices

Reported risk: Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.

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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