MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable...

FDA Device Recall #Z-2299-2013 — Class I — August 13, 2013

Recall Summary

Recall Number Z-2299-2013
Classification Class I — Serious risk
Date Initiated August 13, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Codman & Shurtleff, Inc.
Location Raynham, MA
Product Type Devices
Quantity 369 units

Product Description

MedStream Programmable Pump; 40ml Pump EMEA 91-4201 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.

Lot / Code Information

OUS: Per recall strategy

Other Recalls from Codman & Shurtleff, Inc.

Recall # Classification Product Date
Z-1571-2014 Class II MedStream Programmable Infusion Pump, 20 mL, Pr... Nov 10, 2015
Z-1572-2014 Class II MedStream Programmable Infusion Pump, 40 mL, Pr... Nov 10, 2015
Z-1684-2015 Class II CODMAN 3000 Series Refill Set- Huber needles. ... Mar 5, 2015
Z-0091-2015 Class II Codman Lumbar Drainage Catheter Kit II with EDS... Sep 15, 2014
Z-0090-2015 Class II Codman EDS 3 Drainage System (no Ventricular Ca... Sep 15, 2014

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.