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Recall Observatory FDA recall evidence

Device product

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

Z-1312-2015

December 24, 2014

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 70216
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-1312-2015

Official wording

Reason: 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.

Code information: Lot No. 68965-1241

Distribution pattern: Saudi Arabia and Portugal

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.