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

Recall Z-2688-2014 — RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

U.S. FDA — Device Enforcement · United States · 2014-08-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2688-2014
Date of alert: 2014-08-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Smith & Nephew, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 66800059

Reported risk: Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

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.

Recall Z-2688-2014 — RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

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