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.
This recall has been terminated (originally issued July 5, 2012).
- Recall Initiated
- June 7, 2012
- Posted
- July 5, 2012
- Terminated
- August 7, 2012
- Recall Number
- Z-1943-2012
- Quantity
- 4 cases x 10 units per case
- Firm Location
- Salt Lake City, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Distribution
Nationwide Distribution including MA
Lot / Code Info
Lot W1112119
Root Cause
Packaging process control
Action Taken
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 all affected products returned. Returned product will be reprocessed to correct for the missing components. Customers with questions were instructed to call Integra Pain Management Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-2311.