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Terminated

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

FDA Recall Z-1312-2015 · Posted 2015-03-23

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFRG
Date Initiated2014-12-24
Date Terminated2015-09-04
Product Quantity2 units

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Saudi Arabia and Portugal

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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