Z-0844-2008

STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers...

Name: Z-0844-2008 STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers...
Creator: Advanced Sterilization Products
Published: 2007-11-12
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2007-11-12 / Terminated

FDA source

Advanced Sterilization Products began a recall of STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX... on 2007-11-12. The reason FDA records is "Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0844-2008
Status: Terminated
Initiated: 2007-11-12
Posted: 2008-02-07
Terminated: 2011-12-19
Recalling firm: Advanced Sterilization Products
Product: STERRAD Sterilizers ( Models 100S, 50, 200) Compatible Medical Device Reference List for US Customers, Document Numbers 15-53229 & 15-53230; STERRAD NX Sterilizers Compatible Medical Device Reference List for NX Customers, Product Code 15-53231; STERRAD NX System Brochure, Product Code AD-53421-001, Advanced Sterilization Products, Irvine, CA
Product code: MLR Sterilizer, Chemical
Reason for recall: Outdated Compatibility Lists: Recalling firm has decided to discontinue dissemination of Compatible Medical Device Reference Lists and instrument assessment activities
FDA root cause: Other
Action: Notification letters, Urgent Product Correction, were sent to customers beginning on November 13, 2007 via UPS overnight. Customers were notified this action was being taken as a result of an investigation by the firm determined that all brand- and model-specific compatibility lists and associated instrument assessments provided to STERRAD Sterilization System customers are now out-of-date. User were instructed to discontinue their use and destroy them.
Quantity in commerce: 9,686 units
Distribution: Worldwide: USA, France, Germany, Italy, The UK, Switzerland, Benelux,Uruguay,Venezuela,Argentina,Chile,Colombia,Ecuador,Belgium, Puerto Rico, Hong Kong,Indonesia,Mexico,Philippines,Australia,Austria,China, Greece,Ireland,Israel, Japan,Korea,Malaysia,Singapore,Taiwan,Thailand, Turkey, Middle East, Peru,Canada,The Czech Republic,Portugal,S Africa, Spain,Sweden,Hungary,Poland,Brazil,Russia,Egypt,India &Slovenia and Canada
Product codes and lots: Product Codes: 15-53229 ( Revision A of the list was released 4/5/2005), 15-53230 (Revision A of the list was released 4/5/2005), 15-53231(Revision A of the list was released 4/5/2005) & AD-53421-001( Revision A of the brochure was released 1/14/2006

Product code MLR

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)