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U.S. Department of Health and Human Services

Enforcement Report - Week of July 24, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. All serial numbers Class I Miscalibrated Fill Level Sensor may affect dosing level 5 US and and 360 OUS Z-1691-2013
MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Product Code:91-4200 (20ml pump) US 91-4200. Intended for the intrathecal delivery of Baclofen or Morphine. All serial numbers Class I Miscalibrated Fill Level Sensor may affect dosing level 2 units US and 735 OUS Z-1690-2013
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