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U.S. Department of Health and Human Services

Class 2 Device Recall Symbiq Infuser

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  Class 2 Device Recall Symbiq Infuser see related information
Date Initiated by Firm February 22, 2010
Date Posted September 09, 2010
Recall Status1 Terminated 3 on April 01, 2011
Recall Number Z-2391-2010
Recall Event ID 56464
510(K)Number K041550  
Product Classification Pump, infusion - Product Code FRN
Product Hospira brand Symbiq Two-Channel Infuser,
LIST No. 16027 Symbiq Two-Channel Infuser,
List Number Configurations:
16027-04-01/03/04, 51/52, 53/54, 79/80,81/82,83/84,87/88 and 89/90 16026-27-89/90,
16027-27-89/90, 16027-13-25/26,53/54,

Distributed by: Hospira, Inc. Morgan Hill, CA
Code Information All units of these List Numbers.
Recalling Firm/
Manufacturer		 Hospira Inc
755 Jarvis Dr
Morgan Hill CA 95037-2810
For Additional Information Contact
408-782-3200
Manufacturer Reason
for Recall		 The clamp may not secure to the IV pole and the pump may slip or fall off. The pump may fall on a person or pull the tubing out of the IV container.
FDA Determined
Cause 2		 Device Design
Action Hospira issued an "Urgent: Device Field Correction" Letter dated February 22, 2010 to all consignees, identifying the reason for the recall and affected product. Customers were informed that they will be contacted by a Hospira representative to replace the affected pole clamps. Consignees can contact Hospira Technical Support Operations at 1-800-241-4002.
Distribution Worldwide Distribution: USA (all states and Puerto Rico) and the countries of Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Singapore. and the UAE.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
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