CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
FDA Recall Z-2774-2015 · Posted 2015-09-16
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Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMED
Date Initiated2015-08-10
Date Terminated2016-05-20
Product Quantity318,632 cases
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).
Firm Action
A Urgent Medical Device Field Safety Notice will be sent to customers on 8/10/15 to inform them 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). The letter provides the customers with the description of the issues and the recommended actions to be taken. Customers are instructed to complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle. For questions regarding the business reply card, customers are instructed to contact Stericycle. Customers with any complaints or suspected problems with CIDEX OPA Solution related to the field safety letter, are instructed to contact 1-888-783-7723.
Root Cause
Under Investigation by firm
Distribution Pattern
US
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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