CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
FDA device recall Z-2774-2015 · posted 2015-09-16 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 318,632 cases
- Distribution
- US
- Date initiated
- 2015-08-10
- Date posted
- 2015-09-16
- Date terminated
- 2016-05-20
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0.55% ORTH-PHTHALALDEHYDE SOLUTION (K030004) | Advanced Sterilization Products | 2003-02-27 |