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.
Enforcement
- Recall Number
- Z-1943-2012
- Event ID
- 61525
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Integra LifeSciences Corp. d.b.a. Integra Pain Management
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 11, 2012
- Initiation Date
- June 7, 2012
- Classification Date
- July 5, 2012
- Termination Date
- August 7, 2012
- Address
- 3498 West 2400 South #1050, N/A, Salt Lake City, UT, 84119, United States
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.
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Lot W1112119
Nationwide Distribution including MA
4 cases x 10 units per case