Recall Z-2459-2015 ยท MED Sterilant, Medical Devices
Advanced Sterilization Products
CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266
| Date | Aug 25, 2015 (initiated Jul 27, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 23,426 cases |
| Distribution | US (nationwide) Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060618 | CIDEX ACTIVATED DIALDEHYDE SOLUTION Johnson & Johnson Co., Apr 12, 2006 |