Cidex® OPA Solution

Cidex OPA Solution is a High Level Disinfectant (HLD) for use in reprocessing heat sensitive medical devices. CIDEX OPA Solution is the first new HLD available in the past thirty five years with the broad materials compatibility of glutaraldehyde. CIDEX OPA Solution will provide rapid high level disinfection in 12 minutes at room temperature (20oC) and is particularly active against mycobacteria, including glutaraldehyde-resistant strains of M. chelonae. CIDEX OPA requires no activation and has minimal odor.

Important Note: Please allow 10 - 14 business days for delivery.

IMPORTANT FIELD SAFETY NOTICE:
Advanced Sterilization Products, the manufacturer of CIDEX, has posted important safety reminders related to the safe use of CIDEX OPA Solution. It is important to follow the warnings and rinsing instructions.

Below is a copy of the notice from Advanced Sterilization Products:

FIELD SAFETY NOTICE:
Reminder to Follow CIDEX® OPA Solution Instructions For Use
PN 20390

Advanced Sterilization Products (ASP) is sending this letter to remind customers of the importance of reading the warnings and following the rinsing instructions of the CIDEX® OPA Solution IFU (Instruction For Use). Although the IFU remains unchanged, ASP has received reports of anaphylaxis following medical procedures involving a device disinfected with CIDEX®OPA Solution. In each of these cases, users failed to follow the IFU for proper rinsing.

Customers may keep their current inventory of CIDEX®OPA Solution and continue to safe ly use the product in accordance with the IFU, which contains the rinsing instructions.

Description of the Issue
ASP conducted a post-market surveillance review of two international complaints for anaphylaxis following medical procedures involving a device disinfected with CIDEX® OPA Solution. Subsequent investigation identified the user failed to follow the rinsing instructions to remove residual CIDEX® OPA Solution from the medical devices post-processing. Improper rinsing may result in the potential for anaphylaxis risk for patient populations beyond bladder cancer patients.

What Actions Are Recommended?
As a reminder customers may keep their current inventory of CIDEX® OPA Solution and continue to safely use the product in accordance with the instructions for use.

• ASP advises the customer :

1. Refer to WARNINGS, section 5 in the IFU for use of CIDEX® OPA Solution.
2. Follow the DIRECTIONS FOR USE Rinsing Instructions (Part B) in the IFU completely and correctly for important information on rinsing when use CIDEX® OPA Solution.
3. Refer to DIRECTIONS FOR USE Rinsing Instructions (Part B), part (a) manual processing, bullet number 5 of the section in the IFU for the risk of CIDEX® OPA Solution residues due to improper rinsing.
4. ALWAYS refer to CIDEX® OPA Solution Wall Chart (AD-09569-0 I-US) as it serves as a constant reminder for users to correctly follow the product's use instructions.
   
   • Ensure anyone in your faci lity impacted by this notification reads this letter carefully. • Maintain a copy of this communication where CIDEX® Solution is stored. • Please complete and return the attached Business Reply Card (double-sided) via mail or by fax to Stericycle: 877-496- 5036. For questions regarding the business reply card, please contact Stericycle at 877-877-03 I7 and reference event# 3070. Why you are being contacted:
   You are receiving this letter because our records indicate you have received CIDEX® OPA Solution. To report any complaints or suspected problems with CIDEX® OPA Solution related to this letter, please contact ASP Customer Support Representative at l-888-783-7723. For questions regarding the business reply card, please contact Stericycle at 877-877-03 17 and reference Event # 3070.
   
   We know you place high value in our products. We appreciate your cooperation in this matter and value you as our customer. ASP is committed to maintaining your confidence in the safety and quality of our products.
   
   Sincerely.
   
   Jacqueline Berretta Vice Pn:sidcnl. Quality :md Rcgulntory Compliance Advanced Sterilization Product
   
   Gubelstrasse 34, 6300 Zug, Switzerland 3070_01_01AS_V1.1