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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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Product Detail

Product Description MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Product Code: 91-4201US (40ml pump) 91-4201 (40ml pump) Intended for the intrathecal delivery of Baclofen or Morphine.
Recall Number Z-1691-2013
Classification Class I
Code Info All serial numbers
Product Distributed Qty 5 US and and 360 OUS
Reason For Recall Miscalibrated Fill Level Sensor may affect dosing level

Event Detail

Event Id 65420
Product Type Devices
Status Ongoing
Recalling Firm Codman & Shurtleff, Inc.
City Raynham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution-USA (nationwide) including the states of FL, NC, NJ, and TX, and the countries of Austria, Australia, Belgium, China, Denmark, Spain, Great Britain, Germany, Italy, Ireland, Luxemburg, Russia, Saudi Arabia, and Turkey.