Z-1629-2008

STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable...

Name: Z-1629-2008 STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable...
Creator: Advanced Sterilization Products
Published: 2008-02-25
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2008-02-25 / Terminated / root cause: design

FDA source

Advanced Sterilization Products began a recall of STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices on 2008-02-25. The reason FDA records is "Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1629-2008
Status: Terminated
Initiated: 2008-02-25
Posted: 2008-08-08
Terminated: 2011-11-21
Recalling firm: Advanced Sterilization Products
Product: STERRAD 50 Sterilization System, Product Code 10050 Used to sterilize heat and moisture sensitive reusable medical devices.
Product code: MLR Sterilizer, Chemical
Reason for recall: Oil mist filter fails allowing oil mist to be emitted into the vicinity of the sterilizer, which may result in the release of a mist, "haze," or "smoke."
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent an Urgent Device Correction letter dated 4/23/08, notifying customers of a situation that may occur with all models of STERRAD Sterilization Systems (100S, 50, 200, NX and 100NX). As a precaution, personnel should leave the room if mist is observed and avoid returning until the mist has cleared. ASP asks that customers circulate this letter to any STERRAD system users within their facility and also to the Chief Administrative Officer, the Director of Biomedical Engineering, Director of Materials Management and the Chief of Nursing. The letter instructs customers on what to do if they experience a filter failure - a) cancel the cycle if the sterilizer is running [and as always, do not use instruments from an incomplete cycle], b) leave the room, c) discontinue use of the STERRAD Sterilizer until the system is repaired. d) Personnel should avoid working in the room until the mist has cleared. The letter advises that ASP service will replace the sterilizer's filter and increase the frequency of filter changes by adjusting the Planned Maintenance (PM) schedule within the software on their STERRAD 100S and STERRAD NX Sterilizer. Per the notice, for each STERRAD Sterilizer model, ASP will do the following: a) STERRAD 200 Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter and gasket assembly at no charge. b) STERRAD NX Sterilizer - beginning April 28, 2008 through October 2008, ASP will install a new filter assembly at no charge and adjust the PM schedule to 650 cycles or 6 months (whichever occurs first). c) STERRAD 100S Sterilizer - beginning April 28, 2008 through October 2008, ASP will adjust the PM schedule to 750 cycles or 6 months (whichever occurs first). d) STERRAD 50 and 100NX Sterilizers - No adjustments to the oil mist filters or PM schedules are required at this time. PMs will be performed as currently scheduled. Information for MedWatch reporting is included in the letter.
Quantity in commerce: 9,950
Distribution: Worldwide Distribution -- including USA and countries of France, Germany, Italy, United Kingdom, 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, Peru, Canada, Czech Republic, Middle East, Portugal, S. Africa, Spain, Sweden, Hungary, Poland, Brazil, Russia, Egypt, India, and Slovenia.
Product codes and lots: all serial numbers

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)