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MedStream Refill Kit, U.S (6 units): 91-4288 recallZ-2298-2013 · Codman & Shurtleff, Inc. · initiated Aug 13, 2013

Class I Terminated All recalls posted in September 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Codman & Shurtleff, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Drug flow rates exceeding programmed flow rates.

FDA root cause category: Use error

What the company is doing

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.

Recall details

Recall number
Z-2298-2013
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Aug 13, 2013
Posted by the FDA
Sep 30, 2013
Recalling firm
Codman & Shurtleff, Inc.
Quantity
0 - product used for internal training purposes only
Product code
LKK
FDA submissions
P890055
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.

Product description

MedStream Refill Kit, U.S (6 units): 91-4288 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.

Code information (models, lots, serial numbers)

N/A

Other devices under the same FDA submission

6 devices cleared under P890055 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 65821).

Sources and updates

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