Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only ...

FDA Device Recall #Z-0533-2014 — Class II — October 28, 2013

Recall Summary

Recall Number Z-0533-2014
Classification Class II — Moderate risk
Date Initiated October 28, 2013
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 359,250

Product Description

Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.

Reason for Recall

Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.

Distribution Pattern

USA Nationwide Distribution and one foreign consignee in Mursalat.

Lot / Code Information

Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,

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.