Z-0688-2016Class II

Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin...

Name: Z-0688-2016 Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin...
Creator: MOOG Medical Devices Group
Published: 2015-12-23
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2015-12-23 / Terminated / root cause: manufacturing process

FDA source

MOOG Medical Devices Group began a recall of Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000... on 2015-12-23. FDA classified it as Class II and gives the reason as "Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0688-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-23
Posted: 2016-02-11
Terminated: 2017-02-21
Recalling firm: Zevex, Inc.
Product: Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
Product code: FRN Pump, Infusion
Reason for recall: Moog is recalling Curlin 4000, 6000, and PainSmart Infusion Pumps manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015 because the master pumps used to calibrate them were out of tolerance and may cause an over delivery of medications and solutions at a rate of 1.2 - 6.8% faster than programmed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Moog Medical Device Group sent an "Urgent Recall Notice" dated December 22, 2015, to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove all of their current Calibration Sets from service before placing these new sets into service. Customers were also instructed to complete and return the Recall Reply Form by fax: 801-264-1051 or email to: [email protected] and for any questions, please contact: Moog Regulatory Affairs at 801-264-1001. For additional information or clarification call 801-264-1001, ext. 112 or via email at: [email protected] Monday through Friday, 8:00 AM to 5:00 PM, Mountain Time.
Quantity in commerce: 11,472
Distribution: Worldwide Distribution - US (nationwide), Guam, and countries of: Australia, Canada, Croatia, Turkey, New Zealand, Saudi Arabia, Japan, Korea, and Italy.
Product codes and lots: All manufactured or serviced by MMDG between March 18, 2015 and November 6, 2015. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0688-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0688-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-11

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)