Z-2325-2012Class III

100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene...

Name: Z-2325-2012 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene...
Creator: Steris Corporation
Published: 2012-08-02
License: https://open.fda.gov/license/

STERIS Corporation / initiated 2012-08-02 / Terminated / root cause: manufacturing process

FDA source

Steris Corporation began a recall of 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the... on 2012-08-02. FDA classified it as Class III and gives the reason as "On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators". 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-2325-2012
Classification: Class III
Status: Terminated
Initiated: 2012-08-02
Posted: 2012-09-06
Terminated: 2013-09-04
Recalling firm: STERIS Corporation
Product: 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Product code: LRT Indicator, Sterilization
Reason for recall: On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Steris sent a Urgent Voluntary Recall Notice letter dated August 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Steris has learned that the VIS-U-All tubing is not performing to product specifications. Upon receipt of replacement product we ask that you destroy any remaining inventory of the affected lot in your possession. In the interim period, should you receive a failing result following a sterilization cycle, the results must be handled in accordance with your internal hospital procedures. We apologize for any inconvenience this matter may cause you. For further questions please call 1-(800) 548-4873.
Quantity in commerce: 77 packs
Distribution: Worldwide Distribution--USA (nationwide) including the states of AL, AZ, CA, FL, IL, IN, KY, LA, MO, MS, NJ, OH, PA, SD, TX, and VA., and the countries of Japan, Peru, and Suriname.
Product codes and lots: Product code KCT; Lot number: 60263

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2325-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2325-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-12	2012-09-06

Product code LRT

K092745Class IIVis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and Heat Seal Pouches, Heat Seal TuSTERIS Corporation / cleared 2010-11-19

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)