MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrath

FDA device recall Z-2297-2013 · posted 2013-09-30 · Terminated

Recall details

Recalling firm

Codman & Shurtleff, Inc.

Reason for recall

Drug flow rates exceeding programmed flow rates.

Action taken

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.

Root cause

Use error

Status

Terminated

Product code

LKK

Quantity affected

832 units

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 Ara

Date initiated

2013-08-13

Date posted

2013-09-30

Date terminated

2014-09-11

Location

Raynham, MA