Recall Z-2684-2016 ยท CAZ Anesthesia Conduction Kit
Integra LifeSciences Corp. d.b.a. Integra Pain Management
INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile.
| Date | Aug 4, 2016 |
| Status | Terminated |
| Reason | Integra LifeSciences is recalling Spinal Trays, Cat No. 3404875, because of the affected recalled Hospira 5% Lidocaine HCL that is a component of some lots of the Spinal Trays. |
| Root cause | Other |
| Action | Integra sent an Urgent Medical Device letter dated August 4, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return unused, affected product. Confirmation of the recall notification delivery via delivery verifiable email; Return of Recall Acknowledgement form; Return & disposition of unused, affected product, if the customer in their response indicates they have affected devices. Any products returned to Integra as a result of the recall will be stored in a segregated, labeled area. |
| Quantity | 200 packages (20 cases) |
| Distribution | US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943319 | GERTIE MARX EPI-SPINAL TRAY Spinal Specialties, Inc., Jun 30, 1995 |