Z-0741-2012

STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200

Name: Z-0741-2012 STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200
Creator: Advanced Sterilization Products
Published: 2012-01-23
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2012-01-23 / Terminated / root cause: manufacturing process

FDA source

Advanced Sterilization Products began a recall of STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: The STERRAD Sterilization System is a... on 2012-01-23. The reason FDA records is "ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0741-2012
Status: Terminated
Initiated: 2012-01-23
Posted: 2012-01-13
Terminated: 2013-09-23
Recalling firm: Advanced Sterilization Products
Product: STERRAD 200 Sterilizer, Hydrogen Peroxide Gas Plasma Sterilizer, Chemical Sterilizer. STERRAD 200; Product Usage: 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: ASP determined that an internal filter in the vacuum pump on the STERRAD 200 System is subject to wear over time.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ASP will send an Urgent Medical Device Correction letter to all affected customers on January 23rd, 2012. The letter describes the product, problem and the actions to be taken. The letter informs customers that ASP has determined that the vacuum pump in the STERRAD 200 System may cause the emission of a slightly increased level of hydrogen peroxide (H2O2) vapor into the surrounding environment if not regularly serviced or replaced. The letter instructed customers to read the "Issue Description" and "Recommendations" sections in the letter, pass on the notice with any staff that work with or around the STERRAD 200, and maintain awareness of this communication until ASP has serviced the system. Also, a list of FAQ was provided. The letter states that ASP will replace, free of charge, the vacuum pumps on all STERRAD 200 Systems that have exceeded the pump manufacturer's recommended service interval. ASP has contracted with Stericycle to manage this field correction. Telephone numbers are provided in the letter: for questions related to this field correction, please contact Stericycle at 1-877-225-9750 and to report any complaints or suspected problems with the System, please contact ASP Professional Services directly at 1-888-783-7723, option # 2.
Quantity in commerce: 395 units
Distribution: Worldwide Distribution - USA (nationwide)
Product codes and lots: Product Code 10201

Product code MLR

K030429Class IISterrad 200 SterilizerAdvanced Sterilization Products / cleared 2003-08-18

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)