Z-0072-2013Class II

This recall is being conducted due to an incomplete recall for RES 57829 Curlin Infusion Administration...

Name: Z-0072-2013 ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration...
Creator: MOOG Medical Devices Group
Published: 2012-09-26
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2012-09-26 / Terminated / root cause: manufacturing process

FDA source

MOOG Medical Devices Group began a recall of ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin... on 2012-09-26. FDA classified it as Class II and gives the reason as "This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin...". 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-0072-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-26
Posted: 2012-10-17
Terminated: 2013-04-05
Recalling firm: Zevex, Inc.
Product: ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration Set, REF 340-4165, Sterile EO, The Curlin Ambulatory Infusion Pump System with disposable PVC Administration Tubing Sets and user accessories, provide a means for the volumetric delivery of fluids used in Parenteral, Enteral, Epidural, Subcutaneous and Intravenous applications.
Product code: FRN Pump, Infusion
Reason for recall: This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable Air-In-Line alarm with specific lot numbers of Curlin Administration Sets used with Curlin Ambulatory Infusion Pumps. The lots associated with this recall were inadvertently omitted from the original recall which has since been terminated by
Root cause tag: manufacturing process
FDA root cause: Process control
Action: MOOG sent a Medical Device Recall Notification letter dated September 26, 2012, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove product from their inventory and return to the firm. Customers were also instructed to contact their distributor to arrange for replacement product. For questions customers were instructed to call 1-800-970-2337, prompt #7. For questions regarding this recall call 801-264-1001.
Quantity in commerce: 12,000 sets
Distribution: Nationwide Distribution including California
Product codes and lots: Product Code/Lot Number: 340-4166/CF1022906; 340-4128-V/CRF10082001; 340-4165/CF1022905.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0072-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0072-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-24	2012-10-17

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)