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

Recall Z-2338-2012 — STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate acces

U.S. FDA — Device Enforcement · United States · 2012-06-19 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2338-2012
Date of alert: 2012-06-19
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Advanced Sterilization Products
Product category: device
Product type: Devices

Reported risk: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.

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.

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