Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101
FDA Recall Z-1899-2008 · Posted 2008-09-22
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Recalling FirmCurlin Medical Llc
Recall StatusTerminated
Product CodeFRN
Date Initiated2008-05-30
Date Terminated2009-06-11
Product Quantity39,366 units for all affected products/models total
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
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide Distribution --- including USA and countries of Australia, Croatia, Germany, Italy, New Zealand, and South Africa.
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.
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