Health knowledge made personal
Join this community!
› Share page:
Go
Search posts:

Class I Medical Device Recall: Symbiq One-Channel Infuser and Symbiq Two-Channel Infuser

Posted Jul 14 2010 9:00pm

Recall Class: I

Date Recall Initiated: April 9, 2010

Products: Symbiq Infuser

Brand Name:
Symbiq One-Channel Infuser
Symbiq Two-Channel Infuser

Model Numbers:
16026 Symbiq One-Channel Infuser
16027 Symbiq Two-Channel Infuser

List Number Configurations:

List-Label-Size
List-Label-Size
16026-04-01/03/04
16027-04-01/03/04
16026-04-51/52
16027-04-51/52
16026-04-53/54
16027-04-53/54
16026-04-79/80
16027-04-79/80
16026-04-81/82
16027-04-81/82
16026-04-83/84
16027-04-83/84
16026-04-87/88
16027-04-87/88
16026-04-89/90
16027-04-89/90
16026-13-25/26
16027-27-89/90
16026-13-53/54
16027-13-25/26
16026-27-89/90
16027-13-53/54

Use: The Symbiq Infusion System is an infusion pump intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

Recalling Firm:
Hospira, Inc.
755 Jarvis Drive
Morgan Hill, CA 95037

Reason for Recall:
There is potential for the device to fail to detect air in line at the end of an infusion.

Public Contact:
Questions should be directed to Hospira, Inc. at 1-800-241-4002. Monday through Friday from 9:00 a.m. to 5 p.m. Eastern Time.

FDA District: San Francisco

FDA Comments:
Hospira mailed clinical bulletins to affected customers on April 9, 2010, and an updated clinical bulletin on June 11, 2010. In the June 11, 2010 letter, Hospira states the user does not have to remove or stop using the Symbiq infusion pump. Hospira also provided recommended mitigation actions for users. A link to the June 11, 2010, letter is provided in Useful Links below.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to the FDA’s MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail, or by FAX.

Useful Links:
Hospira Symbiq Clinical Bulletins and Recall Notice
FDA Infusion Pump Initiative web page

    
Post a comment
Write a comment:

Related Searches