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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

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 Class 1 Recall
Symbiq Infuser
see related information
Date Posted September 08, 2010
Recall Number Z-2381-2010
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
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.
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.
 
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