Class 3 Device Recall Single Shot Epidural Tray

• Date Initiated by Firm: June 07, 2012
• Date Posted: July 05, 2012
• Recall Status: Terminated on August 07, 2012
• Recall Number: Z-1943-2012
• Recall Event ID: 61525
• 510(K)Number: K945484
• Product Classification: Anesthesia conduction kit - Product Code CAZ
• 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.
• Code Information: Lot W1112119
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp. d.b.a. Integra Pain Management; 3498 West 2400 South #1050; Salt Lake City UT 84119
• For Additional Information Contact: Ms. Judith E. O'Grady; 609-936-2311
• Manufacturer Reason for Recall: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
• FDA Determined 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 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.
• Quantity in Commerce: 4 cases x 10 units per case
• Distribution: Nationwide Distribution including MA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAZ