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

FDA Recall #Z-1312-2015 — Class II — December 24, 2014

Recall #Z-1312-2015 Date: December 24, 2014 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

Advanced Sterilization Products — Irvine, CA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

2 units

Distribution

Saudi Arabia and Portugal

Code Information

Lot No. 68965-1241

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated