Z-0702-2018Class II

MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike...

Name: Z-0702-2018 MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike...
Creator: Zevex Incorporated (dba Moog Medical Medical Devices Group)
Published: 2017-11-10
License: https://open.fda.gov/license/

Zevex, Inc. / initiated 2017-11-10 / Terminated / root cause: manufacturing process

FDA source

Zevex Incorporated (dba Moog Medical Medical Devices Group) began a recall of MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port... on 2017-11-10. FDA classified it as Class II and gives the reason as "Particulate found on the Curlin spike". 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-0702-2018
Classification: Class II
Status: Terminated
Initiated: 2017-11-10
Posted: 2018-02-23
Terminated: 2018-12-12
Recalling firm: Zevex, Inc.
Product: MOOG Curlin Infusion Administration Set, Ref 340-4169, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Ultrasite Needleless Injection Port (Positive Pressure), Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be used with the Moog Curlin infusion Pump. The pump can be used for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Particulate found on the Curlin spike.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm began issuing letters via USPS certified mail with return receipt on 11/10/2017 and concluded on 11/13/2017. Updated letters dated 11/20/2017 were issued via certified mail to distributors and to medical facilities. The distributor letter emphasized their instructions to notify downstream accounts. The medical facility letter updated lot numbers. The letter described the issue, risk to health, and actions the customer was to take. A response form was enclosed to report whether the customer has inventory they are not returning, that they no longer have inventory of the product, or the amount of product being returned for replacement. The form was to be returned via FAX or email.
Quantity in commerce: 785/20-administration set cases
Distribution: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.
Product codes and lots: UDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0702-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0697-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0698-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0699-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0700-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0701-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23
Z-0702-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-07	2018-02-23

Product code FPA

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)