Smiths Medical Medfusion Model 3500 Syringe Infusion Pump, Software version V4.1.5. A small, lightweight and portable sy

FDA device recall Z-1019-2009 · posted 2009-03-09 · Terminated

Recall details

Recalling firm

Smiths Medical MD, Inc.

Reason for recall

Delay in therapy. Keypad issues with Medfusion Syringe Infusion Pump, model numbers 3500-306 and 3500-415 ("Pump") have occurred during implementation or shortly after first being placed into use. These issues can be intermittent, and may render the Pump inoperable or the Pump may not respond to certain keypad button presses.

Action taken

Consignees were initially notified of the recall via a telephone conversation beginning December 18, 2008 and continued through January 2009. After the initial telephone contact, an "Urgent Medical Device Recall" letter dated December 22, 2008 was sent via electronic mail. The letter was addressed to "Affiliates, Distributors, Clinicians, and other Customers". The letter gave a Description of the Problem and Advise on Action to be Taken by the User. Direct questions to Smiths Medical Customer Service department at 1-800-426-2448 (option 1, then option 3). A Smiths Medical Customer Service Representative will have contacted customers. These pumps will be fitted with new keypads with gold connectors. A second Smiths Medical "Urgent Medical Device Recall Additional Affected Units"recall letter was sent after the recall was expanded. The second letter dated March 6, 2009 was addressed to Safety/Risk Mangers, Healthcare Providers, Biomedical Engineers, Distributors, Clinicians and other Customers. The letter listed the Details of Affected Devices, Description of the Problem, Advise on Action to be Taken by the User, Results of Investigation and Contact Details.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

FRN

Quantity affected

2552

Distribution

Worldwide, including USA, AMERICAN SAMOA, AUSTRALIA, CANADA, CHILE, GERMANY, UNITED KINGDOM, HONG KONG, IRELAND, ISRAEL, SOUTH KOREA, NETHERLANDS, SAUDI ARABIA, SWEDEN

Date initiated

2008-12-18

Date posted

2009-03-09

Date terminated

2012-07-06

Location

Saint Paul, MN

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