Recall Z-0403-2014— Advanced Sterilization Products

Name: FDA recall Z-0403-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-11

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2013-11-11, terminated 2014-01-22. It names one FDA 510(k) clearance: K042116. Product: STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.. Reason: Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2013-11-11
Terminated: 2014-01-22
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K042116 — STERRAD NX STERILIZERAdvanced Sterilization Products·cleared 2005-04-22

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 NX, Product Code: 10033 The STERRAD Steri lization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization systems because ASP has determined that the bronchoscopes may contain a polyurethane material in the suction channel location that is not listed in the current claims for interior channels (lumens) for processing in STERRAD systems.

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