Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | 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 medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration. |
|---|---|
| Recall Number | Z-1943-2012 |
| Classification | Class III |
| Code Info | Lot W1112119 |
| Product Distributed Qty | 4 cases x 10 units per case |
| Reason For Recall | Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. |
Event Detail
| Event Id | 61525 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| City | Salt Lake City |
| State | UT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-07 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide Distribution including MA |
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