Z-1669-2012

Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged

Name: Z-1669-2012 Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged
Creator: MOOG Medical Devices Group
Published: 2012-05-18
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2012-05-18 / Terminated / root cause: manufacturing process

FDA source

MOOG Medical Devices Group began a recall of Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilization using Ethylene Oxide. The Curlin... on 2012-05-18. The reason FDA records is "Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what...". 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-1669-2012
Status: Terminated
Initiated: 2012-05-18
Posted: 2012-05-30
Terminated: 2013-02-22
Recalling firm: Zevex, Inc.
Product: Non-DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged, product code: 340-4166, Method of Sterilization using Ethylene Oxide. 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: FPK Tubing, Fluid Delivery
Reason for recall: Moog Medical Device Group became aware on March 23, 2012 via customer complaint, of a reversed pump segment on an Administration Set. This malfunction could reverse the flow of fluid or medication backwards from what was intended.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm, Moog Medical Device Group, sent an "Urgent Field Safety Notice" dated May 21, 2012 via certified letter and a press release direct to consignees/customers. The notice describes the product, problem and actions to be taken. The customers were instructed to do the following: If purchased by distributor -remove suspect product from inventory; contact your distributor to arrange replacement product and request a shipping return label as per the distributor's process and ship product to their location. If purchased by Moog-remove suspect product from inventory, contact Moog Customer Service at 1-800-970-2337, prompt #7 and Moog customer service will provide a call tag for convenient product return. For additional information or clarification, please contact the Post Market Surveillance Manager at (801) 264-1001, ext. 224 or via email at: [email protected].
Quantity in commerce: 7,900 sets.
Distribution: Nationwide distribution: USA including states of: AZ, CA, FL, IL, KS, MA, MI, MD, NC, ND, NY, OK, OH, and TX.
Product codes and lots: CF1207592

Product code FPK

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)