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Medical Device Recalls
Class 2 Recall
ambIT

See Related Information
Date Recall
Initiated
October 10, 2006
Date Posted November 16, 2006
Recall Number Z-0188-2007
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 , Utah 84088-8320
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.
Action Consignees were notified by letter on 10/10-11/2006.
Quantity in Commerce 4956 units
Distribution Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
 

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