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U.S. Department of Health and Human Services

Class 2 Device Recall ambIT

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 Class 2 Device Recall ambITsee related information
Date Initiated by FirmOctober 10, 2006
Date PostedNovember 16, 2006
Recall Status1 Terminated 3 on May 26, 2011
Recall NumberZ-0187-2007
Recall Event ID 36505
510(K)NumberK002434 K033325 K052221 
Product Classification Ambulatory infusion pump cassette. - Product Code FRN
ProductambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah.
Code Information REF 220266, 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 2		Other
ActionConsignees were notified by letter on 10/10-11/2006 and told to immediately discontinue use/quarantine all affected cassettes. .
Quantity in Commerce2000 units
DistributionWorldwide, including USA, Belgium, France, Germany, Italy, Singapore, Venezuela.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FRN
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