The Recall Desk
ModerateFDA (Devices)·Z-0698-2018·Announced 2018-03-07

Moog Curlin Infusion Set Recalled for Particulate Contamination

Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets because particulate matter was found on the spike.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is particulate contamination, which is a quality defect. No specific injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall involving low-risk contamination or labeling/quality errors.

Plain-English summary

Zevex Incorporated (dba Moog Medical Medical Devices Group) is recalling the MOOG Curlin Infusion Administration Set, Reference 340-4133. The recall is due to the discovery of particulate matter on the Curlin spike. The affected product is a sterile, prescription-only administration set used with the Moog Curlin Ambulatory Volumetric Infusion Pump for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

The recall covers 756 cases, each containing 20 administration sets. The affected lot numbers are CF1519507, CF1522502, CF1524406, and CF1528008. The UDI for the product is 38148440000488. Distribution was nationwide, including government and military channels, as well as foreign distribution to Canada, Saudi Arabia, Turkey, Croatia, the United Arab Emirates, and Australia.

Healthcare facilities and distributors should stop using the affected product and contact the manufacturer for instructions on return or replacement. Patients currently using the device should consult their healthcare provider regarding the recall.

The recalled product

Product
MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Admini

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 (5)

  • UDI 38148440000488
  • Lot/serial numbers: CF1519507
  • CF1522502
  • CF1524406
  • and CF1528008.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Zevex Incorporated (dba Moog Medical 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 6 products in this recall →

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

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