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Terminated

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.

FDA Recall Z-0744-2014 · Posted 2014-01-14

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMLR
Date Initiated2013-12-16
Date Terminated2014-03-27
Product Quantity5584 units

Reason for Recall

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.

Firm Action

Advanced Sterilization Products (ASP) sent an Urgent Medical Device Field Safety Notification dated December 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the customer response forms. Customers with questions were also instructed to contact ASP Professional Services directly at (888) 783-7723 and select option number 2. For questions regarding this recall call 949-453-6400.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042116STERRAD NX STERILIZERAdvanced Sterilization Products · 2005-04-22K023290STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products · 2003-04-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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