Z-0044-2014Class II

STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used...

Name: Z-0044-2014 STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used...
Creator: Advanced Sterilization Products
Published: 2013-09-18
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2013-09-18 / Terminated / root cause: labeling and UDI

FDA source

Advanced Sterilization Products began a recall of STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable... on 2013-09-18. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0044-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-18
Posted: 2013-10-22
Terminated: 2014-01-13
Recalling firm: Advanced Sterilization Products
Product: STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Product code: MLR Sterilizer, Chemical
Reason for recall: Advanced Sterilization Products (ASP) is recalling the three lots (13F049, 13F050, 13F051) STERRAD 100NX Cassettes because ASP has determined that the leak indicator on the cassettes is effective for only 12 months of the cassette's labeled 15-month shelf-life.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Advanced Sterilization Products (ASP) sent an Urgent Medical Device Recall letter on September 18, 2013, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were instructed to examine their inventory and return all affected cassettes using the enclosed prepaid UPS return lave to Stericycle. Customers were asked to count their inventory and record the data on the enclosed Business Reply Card and Packing Slip. Customers were asked to provide the notice to anyone in their facility that needs to be informed. Customers were also asked to maintain a copy of the notice with the affected product. Customers with questions or suspected problems were instructed to contact Stericycle directly at 1-877-257-7119. For questions regarding this recall call 949-453-6400.
Quantity in commerce: 2,995 units
Distribution: Nationwide Distribution
Product codes and lots: Lot# 13F050, 13F051, 13F049

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0044-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0044-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-22

Product code MLR

K071385Class IISterrad 100Nx SterilizerAdvanced Sterilization Products / cleared 2007-11-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)