FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: STERRAD 100NX Cassettes The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Recall number
- Z-0044-2014
- 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.
- Status
- Terminated
- Initiated
- 2013-09-18
- Posted
- 2013-10-22
- Terminated
- 2014-01-13
- Reason
- 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
- 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
- 2,995 units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot# 13F050, 13F051, 13F049
- 510(k) numbers
- ["K071385"]
- PMA numbers
- not on file
- Product code
- MLR
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28