The Recall Desk
HighFDA (Devices)·Z-2053-2019·Announced 2019-07-31

MOOG Curlin Infusion Administration Set Recalled for Filter Leaks

Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used for infusions that has a functional defect (leaking at the filter). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Zevex Incorporated (dba MOOG Medical Devices Group) is recalling MOOG Curlin Infusion Administration Sets, REF 340-4130. The recall involves 569 20-set cartons of the sterile administration sets, which are used with the Moog Curlin Infusion Pump for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

The recall was initiated because the administration sets leaked at the filter. The affected lot numbers are CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, with UDI 38148440000464. Distribution was made to Georgia, Illinois, Kansas, Massachusetts, Michigan, and Ohio. There was no foreign, military, or government distribution.

Healthcare facilities and consumers should stop using the affected infusion administration sets and contact Zevex Incorporated for further instructions or a replacement.

The recalled product

Product
MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for intraveno

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot numbers CF1819415
  • CF1820215
  • CF1821616
  • CF1822914
  • and CF1823615
  • UDI 38148440000464.

Distribution

Distributed in 6 states:

Part of a larger recall action

This product is one of 2 recalled by Zevex Incorporated (dba MOOG Medical Devices Group) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Zevex Incorporated (dba MOOG Medical Devices Group)

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