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.
FDA Recall Z-2375-2015 · Posted 2015-08-13
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Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2015-07-17
Date Terminated2016-05-20
Product Quantity1465 units
Reason for Recall
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."
Firm Action
A Urgent recall letter will be sent to customers to inform them that Advanced Sterilization Products (ASP) is recalling the Wall Chart of the 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. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete a business reply card for their acknowledgement of the customer letter and documentation of the removal and replacement of the wall chart. Customers are instructed to complete and return the attached Business Reply Card via mail or fax to Stericycle: 877-497-3125. Customers with questions are instructed to contact SteriCycle at 866-737-5389 and reference event #6677.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide Distribution.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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