Recall Z-0624-2018 ยท KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Aesculap Implant Systems LLC
JS Series SterilContainer S2 System
| Date | Feb 15, 2018 (initiated Sep 8, 2017) |
| Status | Terminated |
| Reason | The JS Series SterilContainer S2 System was released to the market place prior to an authorized FDA 510K clearance. No other Aesculap SterilContainer System products are impacted by this recall. |
| Root cause | No Marketing Application |
| Action | On August 24, 2017 a Medical Device Recall(Reference 2916714-08/24/2017-010R) was issued requesting that all customers take the following steps: 1.Review the Urgent Medical Device Recall Notification Letter in its entirety and ensure that all users in your organization and other concerned persons are informed about this recall and immediately discontinue use. 2. Determine your current inventory of affected containers within your facility. Immediately quarantine the affected products. A sales representative will come to your facility and remove your affected product and immediately return i |
| Quantity | 292 units |
| Distribution | Nationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.