Medical device recalls Moderate risk

Advanced Sterilization Products recalls Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both meta…

Recall date
July 17, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2375-2015
FDA classification
Class II
Brand / firm
Advanced Sterilization Products
Sold / distributed
Nationwide Distribution.

Why it was recalled

Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

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