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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

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

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
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