Date Initiated by Firm | May 30, 2008 |
Date Posted | September 22, 2008 |
Recall Status1 |
Terminated 3 on June 11, 2009 |
Recall Number | Z-1899-2008 |
Recall Event ID |
48639 |
510(K)Number | K981816 |
Product Classification |
Infusion Pump - Product Code FRN
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Product | Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 |
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
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For Additional Information Contact | Michael L. Henderson 801-264-1001 Ext. 109 |
Manufacturer Reason for Recall | Curlin Medical has investigated five cases of over-delivery/free-flow in the past eight months involving Curlin ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber door (platen) had become deformed in a manner that permitted gravity flow. The firm's investigations have identified the cause of this deformity to have been a result of the pump being dropped with the door (p |
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 |
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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.
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510(K) Database | 510(K)s with Product Code = FRN
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