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Medical Device Recalls
Class 2 Recall
ambIT
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Date Recall Initiated |
October 10, 2006
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Date Posted |
November 16, 2006
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Recall Number |
Z-0188-2007
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Product |
ambIT Ambulatory Infusion Pump Cassette; Filterless, Male, Sterile, Vol. 2.3ml, REF 220267, Sorenson Medical, Inc., West Jordan, Utah.
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Code Information |
REF 220267, all serial numbers
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Recalling Firm/ Manufacturer |
Sorenson Medical, Inc.
1375 W 8040 S
West Jordan
, Utah
84088-8320
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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.
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Action |
Consignees were notified by letter on 10/10-11/2006.
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Quantity in Commerce |
4956 units
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Distribution |
Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
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