Recall Z-2459-2015— Advanced Sterilization Products

Name: FDA recall Z-2459-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-27

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2015-07-27, terminated 2016-07-06. It names one FDA 510(k) clearance: K060618. Product: CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266. Reason: Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2015-07-27
Terminated: 2016-07-06
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K060618 — CIDEX ACTIVATED DIALDEHYDE SOLUTIONJohnson & Johnson Co.·cleared 2006-04-12

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

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

Reason for recall

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

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