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Terminated

STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

FDA Recall Z-0842-2015 · Posted 2014-12-22

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeFLF
Date Initiated2014-11-04
Date Terminated2015-08-04
Product Quantity19,978 units total (9,792 units in US)

Reason for Recall

Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide.

Firm Action

A customer notification letter dated 11/21/2014 will be sent to all customers who purchased the STERRAD 50, STERRAD 100S, STERRAD 200, STERRAD 100NX, and STERRAD NX System Cassettes. The letter informs the customers of the problems identified and the actions to be taken.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023290STERRAD 50 & STERRAD 100S STERILIZERSAdvanced Sterilization Products · 2003-04-03

Official Source

View FDA Recall →

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

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