Moog Curlin Infusion Administration Set Recalled for Particulate Matter
Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets due to particulate matter found on the spike.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk of harm (particulate matter) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Zevex Incorporated (dba Moog Medical Medical Devices Group) is recalling specific lots of MOOG Curlin Infusion Administration Sets, Reference 340-4168. The recall was initiated because particulate matter was found on the Curlin spike. The affected product is a sterile administration set used with the Moog Curlin Ambulatory Volumetric Infusion Pump for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
The recall covers 2,417 cases, with each case containing 20 administration sets. Distribution was nationwide, including government and military channels, as well as foreign distribution to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia. The affected lot/serial numbers are CF1517404, CF1519506, CF1521211, CF1522501, CF1526503, CF1530704, CF1611001, and CF1618152.
Healthcare facilities and consumers should stop using the affected administration sets and contact Zevex Incorporated for further instructions or replacement. The FDA has classified this as a Class II recall.
The recalled product
- Product
- MOOG Curlin Infusion Administration Set, Ref 340-4168, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and distal Female Luer Y-Site with Check Valve, Anti-Siphon Valve included for Free Flow Protection, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric…
- Hazard
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 (9)
- UDI 38148440000587
- Lot/serial numbers: CF1517404
- CF1519506
- CF1521211
- CF1522501
- CF1526503
- CF1530704
- CF1611001
- and CF1618152.
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)
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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
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