Recall Z-2774-2015— Advanced Sterilization Products

Name: FDA recall Z-2774-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-10

Class II · Terminated

Class II FDA medical device recall by Advanced Sterilization Products, initiated 2015-08-10, terminated 2016-05-20. It names one FDA 510(k) clearance: K030004. Product: CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.. Reason: Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use)..

Recalling firm: Advanced Sterilization Products
Classification: Class II
Status: Terminated
Initiated: 2015-08-10
Terminated: 2016-05-20
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K030004 — 0.55% ORTH-PHTHALALDEHYDE SOLUTIONAdvanced Sterilization Products·cleared 2003-02-27

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 OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Reason for recall

Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).

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