STERRAD 100NX Cassettes recallZ-0044-2014 · Advanced Sterilization Products · initiated Sep 18, 2013
Class II Terminated All recalls posted in October 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Advanced Sterilization Products or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0044-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 18, 2013
- Posted by the FDA
- Oct 22, 2013
- Recalling firm
- Advanced Sterilization Products
- Quantity
- 2,995 units
- Product code
- MLR
- FDA submissions
- K071385
- Distribution
- Nationwide Distribution
Product description
STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Code information (models, lots, serial numbers)
Lot# 13F050, 13F051, 13F049
Other devices under the same FDA submission
5 devices cleared under K071385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- STERRAD™ 10104Advanced Sterilization Products Services Inc. · Sterilizer, chemical259 reports
- STERRAD™ 10104-003Advanced Sterilization Products Services Inc. · Sterilizer, chemical92 reports
- STERRAD™ 10144Advanced Sterilization Products Services Inc. · Sterilizer, chemical44 reports
- STERRAD™ 10104-002Advanced Sterilization Products Services Inc. · Sterilizer, chemical23 reports
- STERRAD™ 10104-004Advanced Sterilization Products Services Inc. · Sterilizer, chemical3 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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