Z-1412-2012

Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly The Curlin...

Name: Z-1412-2012 Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly The Curlin...
Creator: MOOG Medical Devices Group
Published: 2012-03-20
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2012-03-20 / Terminated / root cause: manufacturing process

FDA source

MOOG Medical Devices Group began a recall of Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly The Curlin Ambulatory Infusion Pump System with disposable PVC... on 2012-03-20. The reason FDA records is "Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use". 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-1412-2012
Status: Terminated
Initiated: 2012-03-20
Posted: 2012-04-13
Terminated: 2012-07-26
Recalling firm: Zevex, Inc.
Product: Epidural OB Administration Set with Non-Vented Bag Spike and 0.2 Micron Filter Packaged Assembly 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: Ambulatory administration sets used with the Curlin Ambulatory Pumps including the 4000 CMS Ambulatory Pump, 6000 CMS Ambulatory Pump and the Pain Smart IOD Ambulatory Pump may leak during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Moog Medical Device Group sent a Medical Device Recall Notification letter dated March 20, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove the affected product from their inventory, contact the distributor or Moog Customer Service at 1-800-970-2337, prompt #7, then return product to distributor or Moog. For additional questions regarding this recall call Moog's Customer Service Department at (800) 970-2337.
Distribution: Worldwide Distribution - USA including AZ,,, CA,,, FL,,, GA,,, KS,,, IL,,, MA,,, MD,,, MI,,, OH,,, PA,,, TX,,, VA,,, WI,,, and the countries of Germany,,, Italy,,, Morocco,,, New Zealand,,, and the United Arab Emirates,,,
Product codes and lots: Product Number: 340-4162 Lot Numbers: CF1121608,,, CF1131106

Product code FRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)