Medical device recalls Moderate risk

Advanced Sterilization Products recalls Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

Recall date
December 24, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1312-2015
FDA classification
Class II
Brand / firm
Advanced Sterilization Products
Sold / distributed
Saudi Arabia and Portugal

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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