Z-2338-2012Class III

STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are...

Name: Z-2338-2012 STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are...
Creator: Advanced Sterilization Products
Published: 2012-06-19
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2012-06-19 / Terminated / root cause: labeling and UDI

FDA source

Advanced Sterilization Products began a recall of STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize... on 2012-06-19. FDA classified it as Class III and gives the reason as "Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2338-2012
Classification: Class III
Status: Terminated
Initiated: 2012-06-19
Posted: 2012-09-07
Terminated: 2013-11-08
Recalling firm: Advanced Sterilization Products
Product: STERRAD NX Cassette, Batch # 12A078. The STERRAD 100S and STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate accessory. The STERRAD Cassettes are used in conjunction with the STERRAD Sterilizers, and each cassette model is for use only in the matching sterilizer model.
Product code: MLR Sterilizer, Chemical
Reason for recall: Advanced Sterilization Products (ASP) is recalling (removing) the Sterrad 100S and Sterrad NX System cassettes because the camera used to verify printing on the Sterrad System cassettes was inadvertently disabled. The STERRAD 100S and STERRAD NX System cases were shipped without verification of proper printing.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Advanced Sterilization Products sent an "URGENT MEDICAL DEVICE RECALL (REMOVAL) letter dated July 16, 2012 to all their customers who purchased the STERRAD 100S and STERRAD NX System cassettes. The letter informed the customers of the problem identified and the actions to be taken. For the STERRAD NX System cassettes, there should be no impact to the functionality of these affected cassettes. Although printing may be smeared, illegible, or missing, the packaging has multiple references to the information, and the cassettes should be usable despite any printing error. For the STERRAD 100S System cassettes, there is a chance that the barcode will be unreadable and the STERRAD 100S Sterilizer will not accept the cassette. Customers were instructed to complete and return the business reply card and packing slip that are included in the letter. Customers were instructed to contact Stericycle at (888) 406-9303 for additional labels. Customers with questions about the recall letter were instructed to contact Stericycle at (888) 406-9303.
Quantity in commerce: 7,550 units
Distribution: Nationwide Distribution.
Product codes and lots: Product Code: 10133

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2338-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2337-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07
Z-2338-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-07

Product code MLR

K042116Class IISterrad Nx SterilizerAdvanced Sterilization Products / cleared 2005-04-22

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)