CLASS II Device recall · Reported 1 Apr 2015 · FDA Enforcement Report

Tyvek Pouch/Roll with Sterrad Chemical Indicator recalled

Advanced Sterilization Products is recalling Tyvek Pouch/Roll with Sterrad Chemical Indicator. The recall was initiated on 24 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 68965-1241

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1312-2015
FDA event ID: 70216
Recalling firm: Advanced Sterilization Products, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 24 Dec 2014
FDA classified: 23 Mar 2015
Reported: 1 Apr 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

24 Dec 2014	Recall initiated by company
23 Mar 2015	Classified by FDA	+89 days
1 Apr 2015	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Saudi Arabia and Portugal

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Lot No. 68965-1241

Where was it sold?

Saudi Arabia and Portugal

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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