Z-0998-2013Class II

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from...

Name: Z-0998-2013 STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from...
Creator: Advanced Sterilization Products
Published: 2012-03-13
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2012-03-13 / Terminated / root cause: design

FDA source

Advanced Sterilization Products began a recall of STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer on 2012-03-13. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied". 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-0998-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-13
Posted: 2013-03-26
Terminated: 2014-05-28
Recalling firm: Advanced Sterilization Products
Product: STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.
Product code: MLR Sterilizer, Chemical
Reason for recall: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.
Root cause tag: design
FDA root cause: Device Design
Action: Advanced Sterilization Products (ASP) sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated March 13, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter informed the customers that ASP recently determined that the push bar located on the STERRAD 200 System Carriage can potentially become dislodged when an excessive load is applied. Customers with questions are instructed to contact Stericycle at (877) 931-0642.
Quantity in commerce: 2,457 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Egypt, Germany, Italy, France, Saudi Arabia, UAE, Japan, Singapore, China, Thailand, Hong Kong, Hungary, Israel, Slovania, Poland, Czech Republic, Taiwan, Sweden, Greece, Korea, Ireland, and United Kingdom.
Product codes and lots: N/A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0998-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0998-2013	Class II	Terminated	Voluntary: Firm initiated	2013-04-03	2013-03-26

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)