Z-1441-2011

Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake...

Name: Z-1441-2011 Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake...
Creator: Zevex International, Inc.
Published: 2011-01-24
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2011-01-24 / Terminated / root cause: manufacturing process

FDA source

Zevex International, Inc. began a recall of Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. The Curlin Ambulatory Infusion Pump... on 2011-01-24. The reason FDA records is "Defect in tubing may trigger false Air-In-Line warning". 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-1441-2011
Status: Terminated
Initiated: 2011-01-24
Posted: 2011-02-25
Terminated: 2011-09-27
Recalling firm: Zevex, Inc.
Product: Curlin Infusion Administration Set, REF 340-4115, Sterile EO, Zevex, Inc., 4314 Zevex Park Lane, Salt Lake City, UT 84123. 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: Defect in tubing may trigger false Air-In-Line warning.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm, MOOG, sent an "Expansion of Moog/Curlin Ambulatory Pump Administration Set Recall" letter dated May 2, 2011 to its customers. This letter informed the customers that this recall has been expanded to included specific lot numbers of Curlin model ambulatory infusion administration sets. The customers were instructed to follow the outlined process in the letter: remove suspect product code from inventory, contact MOOG Customer Service at 1-800-970-2337, prompt #7, contact your distributor to arrange replacement product, request a shipping return label as per the distributor's process and ship back to their location and follow the temporary solution outlined in the letter. Moog Customer Service will provide a call tag for convenient product return. If you have any questions contact MOOG Customer Service at 1-800-970-2337. The firm, MOOG, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated January 24, 2011 to all customers. The letter described the product, problem and actions to be taken by the customers. The customers were instructed to remove suspect product code from inventory; contact their distributor to arrange replacement product, if purchased from distributor and request shipping return label per distributors process and ship back to their location or contact MOOG Customer Service at 800-970-2337, prompt #7, if purchased directly from MOOG and MOOG Customer Service will provide a call tag for convenient product return; follow the temporary solution provided until replacements are administered; and complete and return the MEDICAL DEVICE CORRECTION REPLY FORM in the self addressed envelope provided. If you have any questions, contact MOOG Customer Service at 800-970-2337.
Quantity in commerce: 27,800 units (US), 200 units (INTL)
Distribution: Worldwide Distribution: USA including states of: AR, CA, FL, IA, KS, MS, NE, NY, OH, OK, TN, TX, and UT; and countries including: Australia, Croatia, France, Germany, Kuwait, New Zealand, Qatar, Saudi Arabia, South Africa, United Arab Emirates, and UK.
Product codes and lots: ***EXPANDED*** Additional Lot Added 05/12/2011: CF1022809. Lot Codes: D005013, D010911, D017304, D017317. .

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