Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each ...
FDA Device Recall #Z-1943-2012 — Class III — June 7, 2012
Recall Summary
| Recall Number | Z-1943-2012 |
| Classification | Class III — Low risk |
| Date Initiated | June 7, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Location | Salt Lake City, UT |
| Product Type | Devices |
| Quantity | 4 cases x 10 units per case |
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.
Reason for Recall
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Distribution Pattern
Nationwide Distribution including MA
Lot / Code Information
Lot W1112119
Other Recalls from Integra LifeSciences Corp. d.b.a. Int...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2868-2016 | Class II | PHS Spinal Tray 24G Gertie Marx, Catalogue No. ... | Aug 24, 2016 |
| Z-2733-2016 | Class II | Integra Cranial Access Kits, Catalogue Nos. INS... | Aug 24, 2016 |
| Z-2684-2016 | Class II | INTEGRA Spinal Tray, Catalogue No: 3404875, Con... | Aug 4, 2016 |
| Z-0193-2016 | Class II | Integra¿ Bone Marrow Biopsy Trays Catalogue No.... | Sep 22, 2015 |
| Z-2056-2015 | Class II | Integra¿ Long Epidural Steroid Injection Needle... | May 1, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.