Device product
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.
Z-1943-2012
Product summary
- Event
- Event 61525
- Status
- Terminated
- Classification
- Class III
- Quantity
- 4 cases x 10 units per case
- Official record key
device-enforcement:Z-1943-2012
Official wording
Reason: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Code information: Lot W1112119
Distribution pattern: Nationwide Distribution including MA
Derived failure modes
-
Unknown
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.