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U.S. Department of Health and Human Services

Class 1 Device Recall Infusion Pumps & Refill Kits

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  Class 1 Device Recall Infusion Pumps & Refill Kits see related information
Date Initiated by Firm August 13, 2013
Date Posted September 30, 2013
Recall Status1 Terminated 3 on September 11, 2014
Recall Number Z-2294-2013
Recall Event ID 65821
PMA Number P890055 
Product Classification Pump, infusion, implanted, programmable - Product Code LKK
Product MedStream Programmable Pump; 40ml - 91-4201US

Usage:
The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir.
Code Information Lot/Serial Number US: NMBKB6, NMBKFF, NMBKC5, NMBKCF, NMBJ3K 
Recalling Firm/
Manufacturer		 Codman & Shurtleff, Inc.
325 Paramount Drive
Raynham MA 02767
For Additional Information Contact Codman Neuro Clinical Support
800-660-2660
Manufacturer Reason
for Recall		 Drug flow rates exceeding programmed flow rates.
FDA Determined
Cause 2		 Use error
Action Codman & Shurtleff, Inc. sent a Medical Device Field Safety Notice letter dated August 13, 2013 to US Consignees via FedEx overnight delivery and International Consignees were notified of the recall via email. The letter identifed the affected products, potential clinical impact, and updated IFU pump filling warning. The letter informed consignees that the Instructions for Use (IFU) and product training materials had been updated by adding a warning statement about potential over infusion if air gets inside the pump reservoir and additional clarifications to reinforce the proper filling technique. Consignees are asked to complete the Field Safety Notice Acknowledgement Form and return it to your local Codman Neuro Sales Representative or fax to: 508-977-6665. Consignees are asked to contact your Codman Neuro representative if they have questions, or contact Codman Neuro Clinical Support at 1-800-660-2660. Please report any malfunction or adverse event related to this device to 1-866-491-0974, Option 2.
Quantity in Commerce 5 units
Distribution Worldwide Distribution - USA Nationwide in the states of NJ, NC, TX, FL and in the countries of Austria, Belgium, Egypt, Germany, Greece, Ireland, Israel, Italy, Luxemborg, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Turkey, and UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = LKK and Original Applicant = Intera Oncology
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