CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
Recall
- Recall Number
- Z-2774-2015
- Event Number
- 71887
- Firm
- Advanced Sterilization Products
- FEI Number
- 3003662624
- Product Code
- MED
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- August 10, 2015
- Posted
- September 16, 2015
- Terminated
- May 20, 2016
- Address
- 33 Technology Dr, Irvine, CA, 92618-2346
Description
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
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).
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.
US
318,632 cases