Z-1899-2008

Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101

Name: Z-1899-2008 Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101
Creator: Curlin Medical Llc
Published: 2008-05-30
License: https://open.fda.gov/license/

Curlin Medical LLC / initiated 2008-05-30 / Terminated

FDA source

Curlin Medical Llc began a recall of Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101 on 2008-05-30. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1899-2008
Status: Terminated
Initiated: 2008-05-30
Posted: 2008-09-22
Terminated: 2009-06-11
Recalling firm: Curlin Medical LLC
Product: Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101
Product code: FRN Pump, Infusion
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 root cause: 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.
Product codes and lots: Serial Numbers for all affected units: 100074 to 210458

Product code FRN

K981816Class IICue Ambulatory Volumetric Infusion PumpBecton Dickinson Curlin, LLC / cleared 1998-12-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)