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U.S. Department of Health and Human Services

Class 2 Device Recall Model 4000 CMS Ambulatory Infusion Pump

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  Class 2 Device Recall Model 4000 CMS Ambulatory Infusion Pump see related information
Date Initiated by Firm May 30, 2008
Date Posted September 22, 2008
Recall Status1 Terminated 3 on June 11, 2009
Recall Number Z-1898-2008
Recall Event ID 48639
510(K)Number K981816  
Product Classification Infusion Pump - Product Code FRN
Product Model 4000 CMS Ambulatory Infusion Pump, Model Number: 350-1101
Code Information Serial Numbers for all affected units: 100074 to 210458
Recalling Firm/
Manufacturer		 Curlin Medical Llc
15751 Graham St
Huntingtn Bch CA 92649-1630
For Additional Information Contact Michael L. Henderson
801-264-1001 Ext. 109
Manufacturer Reason
for Recall		 Over-delivery/free-flow involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow.
FDA Determined
Cause 2		 Other
Action On May 30, 2008, Curlin Medical began distribution of a "Voluntary Field Correction Advisory Notice" to all customers in the United States via USPS Registered Mail. The Notice informed customers of the problem and gave the customers (1) Guidelines on testing pump volumetric accuracy, (2) Updated user manuals to elevate the "caution" statement related to dropped pumps to a "warning" statement, and (3) A warning label to be located on the pump: "Warning: Impact may cause damage. If dropped, pump must be checked for accuracy prior to use". A toll free number (888-287-5999) was given for customers experiencing issues that require immediate assistance.
Quantity in Commerce 39,366 units for all affected products/models total
Distribution Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.
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 = BECTON DICKINSON CURLIN, LLC.
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