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

Recall Z-0052-2015 — ZOLL Pro-padz Sterile Multi-Function Electrodes (MFE) Part Number: 8900-4012 Product Usage: These MFE Electrodes are used in connection with ZOLL Defibrillators for Adult patients. These disposable single use MFEs are processed through Gamma Radiation to a SAL of 10-6 per International/ Natio

U.S. FDA — Device Enforcement · United States · 2014-09-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0052-2015
Date of alert: 2014-09-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Bio-Detek, Inc.
Product category: device
Product type: Devices

Reported risk: Product sterility is not assured

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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