Recall Z-2375-2015— Advanced Sterilization Products

Name: FDA recall Z-2375-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-17

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2015-07-17, terminated 2016-05-20. It names one FDA 510(k) clearance: K142454. Product: Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.. Reason: Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators.".

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2015-07-17
Terminated: 2016-05-20
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K142454 — STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products·cleared 2015-04-03

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

Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.

Reason for recall

Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System because it incorrectly states "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators."

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