Moog Curlin Infusion Sets Recalled for Particulate Contamination
Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.
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 with a contamination hazard (particulate matter) where no specific injuries or illnesses are reported in the source text, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zevex Incorporated (dba Moog Medical Medical Devices Group) is recalling 785 cases of Moog Curlin Infusion Administration Sets, Reference 340-4169. The recall was initiated because particulate matter was found on the Curlin spike of the administration sets.
The affected products are sterile infusion sets packaged 20 per box, intended for use with the Moog Curlin Ambulatory Volumetric Infusion Pump. The specific lot numbers involved are CF1520208, CF1522301, and CF1532971. The UDI for the product is 38148440000594.
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 providers and consumers should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- 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 Ambula
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 (4)
- UDI 38148440000594
- Lot/serial numbers: CF1520208
- CF1522301
- and CF1532971.
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 →Related recalls
Same manufacturer · Zevex Incorporated (dba Moog Medical Medical Devices Group)
See all →- HighMoog Curlin Infusion Administration Set Recalled for Particulate Matter
FDA (Devices) · 2018-03-07
- ModerateMoog Curlin Infusion Set Recalled for Particulate Contamination
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- HighMoog Curlin Infusion Sets Recalled for Particulate Matter on Spike
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- HighMoog Curlin Infusion Administration Set Recalled Due to Particulate Matter
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- HighMoog Curlin Infusion Administration Set Recalled for Particulate Matter
FDA (Devices) · 2018-03-07
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