CLASS II Device recall · Reported 7 Mar 2018 · FDA Enforcement Report

MOOG Curlin Infusion Administration Set recalled by Zevex Incorporated (

Zevex Incorporated ( is recalling MOOG Curlin Infusion Administration Set, distributed nationwide in the US. The recall was initiated on 10 Nov 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.
Quantity recalled785/20-administration set cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-0702-2018
FDA event ID
78573
Recalling firm
Zevex Incorporated (, Salt Lake City, UT
Classification
Class II
Status
Terminated
Recall initiated
10 Nov 2017
FDA classified
23 Feb 2018
Reported
7 Mar 2018
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Particulate Matter
Device type
Infusion Pumps

Timeline

10 Nov 2017Recall initiated by company
23 Feb 2018Classified by FDA+105 days
7 Mar 2018Published in enforcement report+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Particulate found on the Curlin spike.

Product as listed by the FDA

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.

Where it was distributed

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

Nationwide

Questions about this recall

Why was it recalled?

Particulate found on the Curlin spike.

Which lots are affected?

UDI 38148440000594, Lot/serial numbers: CF1520208, CF1522301, and CF1532971.

Where was it sold?

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 78573

This product is part of a recall event; the main page for the event is MOOG Curlin Infusion Administration Set recalled by Zevex Incorporated (.

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