Class 2 Device Recall ambIT

• Date Initiated by Firm: October 10, 2006
• Date Posted: November 16, 2006
• Recall Status: Terminated on May 26, 2011
• Recall Number: Z-0188-2007
• Recall Event ID: 36505
• 510(K)Number: K002434 K033325 K052221
• Product Classification: Ambulatory infusion pump cassette. - Product Code FRN
• Product: ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah.
• Code Information: REF 220267, all serial numbers
• Recalling Firm/ Manufacturer: Sorenson Medical, Inc.; 1375 W 8040 S; West Jordan UT 84088-8320
• For Additional Information Contact: 801-352-6267
• Manufacturer Reason for Recall: Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
• FDA Determined Cause: Other
• Action: Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .
• Quantity in Commerce: 4956 units
• Distribution: Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
• 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.