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U.S. Department of Health and Human Services

Class 2 Device Recall ambIT Intermittent infusion pump

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  Class 2 Device Recall ambIT Intermittent infusion pump see related information
Date Initiated by Firm May 03, 2006
Date Posted July 01, 2006
Recall Status1 Terminated 3 on August 09, 2006
Recall Number Z-1188-06
Recall Event ID 35359
510(K)Number K033425  
Product Classification Intermittent infusion pump - Product Code FRN
Product ambIT Ambulatory Infusion Therapy Intermittent Pump
Code Information Catalog Number: 220245. All serial numbers.
Recalling Firm/
Manufacturer		 Sorenson Medical, Inc.
1375 W 8040 S
West Jordan UT 84088-8320
For Additional Information Contact
801-352-1888
Manufacturer Reason
for Recall		 Intermittent Infusion pump may continually dispense medication under certain conditions.
FDA Determined
Cause 2		 Other
Action All direct accounts were contacted by email and phone on 05/03/2006. Distributors were instructed to identify end users for Recalling Firm notification
Quantity in Commerce 72 pumps
Distribution Worldwide distribution (including-states of IL, KS, NJ, PA, WA. , countries of Germany, Malaysia, New Zealand, Slovenia.
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 = SORENSON MEDICAL, INC.
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