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U.S. Department of Health and Human Services

Class 1 Device Recall Symbiq Infuser

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  Class 1 Device Recall Symbiq Infuser see related information
Date Initiated by Firm March 26, 2010
Date Posted September 08, 2010
Recall Status1 Terminated 3 on March 30, 2012
Recall Number Z-2381-2010
Recall Event ID 56523
510(K)Number K041550  
Product Classification infuser - 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 CA 95037-2810
For Additional Information Contact
408-782-3200
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		 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 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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