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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Event Detail

Event ID 61525
Product Type Devices
Status Ongoing
Recalling Firm Integra LifeSciences Corp. d.b.a. Integra Pain Management
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-07
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including MA

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Lot W1112119 Class III Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. 4 cases x 10 units per case Z-1943-2012
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