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

Recall Z-0744-2014 — STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

U.S. FDA — Device Enforcement · United States · 2013-12-16 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0744-2014
Date of alert: 2013-12-16
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Advanced Sterilization Products
Product category: device
Product type: Devices

Reported risk: Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S Sterilization Systems because some healthcare workers detected odors or smells possibly emanating from STERRAD Systems.

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.

Recall Z-0744-2014 — STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD NX process to inactivate microorganisms on a broad range of medical devices and surgical instruments.

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