Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

MedStream Refill Kit Recalled by Codman & Shurtleff, Inc. Due to Drug flow rates exceeding programmed flow rates.

Date: August 13, 2013
Company: Codman & Shurtleff, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Codman & Shurtleff, Inc. directly.

Affected Products

MedStream Refill Kit, U.S: 91-4287 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.

Quantity: 5 units

Why Was This Recalled?

Drug flow rates exceeding programmed flow rates.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Codman & Shurtleff, Inc.

Codman & Shurtleff, Inc. has 58 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report