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

Recall Z-0402-2014 — STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

U.S. FDA — Device Enforcement · United States · 2013-11-11 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0402-2014
Date of alert: 2013-11-11
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 and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in 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-0402-2014 — STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

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