ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah.
FDA Recall Z-0187-2007 · Posted 2006-11-16
Recalling FirmSorenson Medical, Inc.
Recall StatusTerminated
Product CodeFRN
Date Initiated2006-10-10
Date Terminated2011-05-26
Product Quantity2000 units
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.
Firm Action
Consignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .
Root Cause
Other
Distribution Pattern
Worldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.