Z-1312-2015Class II

Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

Name: Z-1312-2015 Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Creator: Advanced Sterilization Products
Published: 2014-12-24
License: https://open.fda.gov/license/

Advanced Sterilization Products / initiated 2014-12-24 / Terminated / root cause: sterility

FDA source

Advanced Sterilization Products began a recall of Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 on 2014-12-24. FDA classified it as Class II and gives the reason as "Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1312-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-24
Posted: 2015-03-23
Terminated: 2015-09-04
Recalling firm: Advanced Sterilization Products
Product: Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
Product code: FRG Wrap, Sterilization
Reason for recall: Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicator because they were shipped to customers after its expiration date of May 18, 2013.
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: A customer notification letter was sent on 12/24/14 to all customers who purchased the expired Tyvek Rolls with STERRAD Chemical Indicator. The letter informs the customers of the problems identified and the actions to be taken.
Quantity in commerce: 2 units
Distribution: Saudi Arabia and Portugal
Product codes and lots: Lot No. 68965-1241

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1312-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-01	2015-03-23

Product code FRG

K141693Class IITyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products / cleared 2014-12-19

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)