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U.S. Department of Health and Human Services

Class 1 Device Recall Symbiq Infuser

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 Class 1 Recall
Symbiq Infuser
see related information
Date Posted September 08, 2010
Recall Status1 Terminated on March 30, 2012
Recall Number Z-2381-2010
Recall Event ID 56523
Premarket Notification
510(K) Number
K041550 
Product Classification Pump, Infusion - Product Code FRN
Product Hospira Inc. Symbiq One- and Two- Channel Infuser, List Numbers 16026 and 16027 respectively.
Code Information List number configurations: 16026-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16027-04-01/03/04, 51/52, 53/54, 79/80, 81/82, 83/84, 87/88, 89/90; 16026-27-89/90, 16026-13-25/26, 53/54; 16027-27-89/90; 16027-13-25/26, 53/54.
Recalling Firm/
Manufacturer
Hospira Inc
755 Jarvis Dr
Morgan Hill, California 95037-2810
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
If the administrator set is removed prior to the cassette carriage fully opening without closing the slide/roller clamp, unrestricted flow and delivery may result.
FDA Determined
Cause 2
DESIGN: Device Design
Action Hospitra Urgent Device Correction Notification mailed on 03/26/2010 via federal express. Tracking done by delivery tracking. Distribution of product continues and has not stopped. Additional notification was issued in 09/2010. A software correction is planned.
Quantity in Commerce 28485 units
Distribution Worldwide distribution: USA, Australia, Canada, Colombia, Costa Rica, Malaysia, Mexico, Puerto Rico, Singapore and the UAE.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRN and Original Applicant = ABBOTT LABORATORIES
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