Recall Z-1943-2012 ยท CAZ Anesthesia Conduction Kit
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed m
| Date | Jul 5, 2012 (initiated Jun 7, 2012) |
| Status | Terminated |
| Reason | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. |
| Root cause | Packaging process control |
| Action | Integra sent an Urgent - Medical Device Recall letter dated June 7, 2012, to one domestic consignee via Federal Express with a recall acknowledgement form followed up with a telephone call. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the Recall Acknowledgement Form including quantity of affected product in their inventory. Customers were also instructed to contact Integra Pain Management Customer Service to arrange for returns of all affected product. Product reconciliation will be performed to account for |
| Quantity | 4 cases x 10 units per case |
| Distribution | Nationwide Distribution including MA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945484 | PIDURAL STEROID SYSTEM Professional Medical Device Consultants, Jun 2, 1995 |