Recall Z-2774-2015 ยท MED Sterilant, Medical Devices
Advanced Sterilization Products
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
| Date | Sep 16, 2015 (initiated Aug 10, 2015) |
| Status | Terminated |
| 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). |
| Root cause | Under Investigation by 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 bu |
| Quantity | 318,632 cases |
| Distribution | US |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION Advanced Sterilization Products, Feb 27, 2003 |