MedStream Programmable Infusion Pump, 40 mL, Product Code: 91-4201 The MedStream programmable pump is intended for the i

FDA device recall Z-1572-2014 · posted 2014-05-09 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

A small number of specific pumps may trigger a low battery alarm at the beginning of the implanted life.

Action taken

Codman Neuro sent an Urgent Field Safety Notice to all affected customers on April 18, 2014. The letter identified the product the problem and the action needed to be taken by the customer. The letter states the reason for recall, information about managing patients with affected pumps, and returning affected non-implanted pumps. You are receiving this voluntary recall notification because our records indicate that you are the recipient of one or more MedStream Pumps affected by this recall. Please do not implant any identified products included in this recall. Please complete the enclosed Acknowledgement Form and fax the completed form to: 001-508-977-6665. It is important that we receive this acknowledgement form, even if you have no affected product in your inventory. You may also e-mail the form to us at Codmanproductcomplaints@dpyus.jnj.com We request that you immediately check all inventory to determine if you have affected product. Please contact your Codman Neuro sales consultant to assist you in the return process. Please use the included instructions to report your inventory status and return affected product. Note this recall applies only to

Root cause

Device Design

Status

Terminated

Product code

LKK

Quantity affected

34

Distribution

Worldwide Distribution including the countries of Belgium Germany, Spain, United Kingdom, Ireland, Italy, Russia and Turkey.

Date initiated

2015-11-10

Date posted

2014-05-09

Date terminated

2015-11-10

Location

Raynham, MA