CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
FDA device recall Z-2459-2015 · posted 2015-08-25 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.
- Action taken
- A Urgent Product Notification Letter dated July 27, 2015, will be sent to customers and distributor who purchased the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24 month shelf life. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the requested information on the enclosed postage paid Business Reply Card and return it to Stericycle. Customers with questions or need additional packing labels are instructed to contact Stericycle at (877) 550-0701, M-F, 8am-5pm ET. Customers are instructed to report complaints or suspected problems with CIDEX Activated Dialdehyde Solution by contacting (888) 783-7723.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 23,426 cases
- Distribution
- US (nationwide) Distribution
- Date initiated
- 2015-07-27
- Date posted
- 2015-08-25
- Date terminated
- 2016-07-06
- 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 |
|---|---|---|
| CIDEX ACTIVATED DIALDEHYDE SOLUTION (K060618) | Johnson & Johnson Co. | 2006-04-12 |