Z-2054-2019Class II

MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented...

Name: Z-2054-2019 MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented...
Creator: Zevex Incorporated (dba MOOG Medical Devices Group)
Published: 2019-02-27
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2019-02-27 / Terminated / root cause: manufacturing process

FDA source

Zevex Incorporated (dba MOOG Medical Devices Group) began a recall of MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve... on 2019-02-27. FDA classified it as Class II and gives the reason as "Administration sets leaked at the filter". 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-2054-2019
Classification: Class II
Status: Terminated
Initiated: 2019-02-27
Posted: 2019-07-23
Terminated: 2021-04-28
Recalling firm: Zevex, Inc.
Product: MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
Product code: FRN Pump, Infusion
Reason for recall: Administration sets leaked at the filter.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued a letter dated 2/27/2019 via regular mail on 2/272019 to their direct accounts describing the issue, risk to health, and the necessary actions to be taken.
Quantity in commerce: 756/20-set cases
Distribution: Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
Product codes and lots: Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2054-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2053-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23
Z-2054-2019	Class II	Terminated	Voluntary: Firm initiated	2019-07-31	2019-07-23

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)