Home / Recalls / Codman & Shurtleff, Inc. / Z-2293-2013

Z-2293-2013 Class I Terminated

Recalled by Codman & Shurtleff, Inc. — Raynham, MA

FDA device recall Z-2293-2013 was initiated by Codman & Shurtleff, Inc. on August 13, 2013 and is designated Class I. Reason for recall: Drug flow rates exceeding programmed flow rates. The recall status is terminated (terminated September 11, 2014). Affected quantity: 2 units.

Recall Details

Product Type: Devices
Report Date: October 9, 2013
Initiation Date: August 13, 2013
Termination Date: September 11, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2 units

Product Description

MedStream Programmable Pump; 20ml - 91-4200US Product 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.

Reason for Recall

Drug flow rates exceeding programmed flow rates.

Distribution Pattern

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.

Code Information

Lot/Serial Number US: NMBJ7K, NMBJ5C

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