Recall Z-0998-2013— Advanced Sterilization Products

Name: FDA recall Z-0998-2013
Creator: U.S. Food and Drug Administration
Published: 2012-03-13

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2012-03-13, terminated 2014-05-28. It names one FDA 510(k) clearance: K030429. Product: STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.. Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2012-03-13
Terminated: 2014-05-28
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030429 — STERRAD 200 STERILIZERAdvanced Sterilization Products·cleared 2003-08-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

STERRAD 200 System Carriage, P/N 10208. Used as a tool to expedite loading and unloading processed items from a STERRAD 200 sterilizer.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD 200 System Carriage because it can potentially become dislodged when an excessive load is applied.

Data sourced from openFDA. This site is unofficial and independent of the FDA.