Moog Curlin Infusion Administration Set Recalled for Particulate Matter
Zevex Incorporated is recalling Moog Curlin Infusion Administration Sets due to particulate matter found on the spike. The recall covers 56,244 cases distributed nationwide and internationally.
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 is classified as FDA Class II, and the presence of particulate matter in a sterile infusion device presents a risk of harm to patients, even though specific injury reports are not detailed in the source text.
Plain-English summary
Zevex Incorporated (dba Moog Medical Medical Devices Group) is recalling the MOOG Curlin Infusion Administration Set, Reference 340-4114. The recall was initiated because particulate matter was found on the Curlin spike. The 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 involves 56,244 cases of 20 administration sets each. 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. The agency has classified this as a Class II recall.
Healthcare facilities and consumers should stop using the affected products immediately. The specific lot and serial numbers involved are listed in the official recall documentation. Users should contact the manufacturer for further instructions on returning or replacing the equipment.
The recalled product
- Product
- MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, 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…
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 (20)
- UDI 38148440000396
- Lot/serial numbers: CF1514703
- CF1514702
- CF1514701
- CF1517405
- CF1517406
- CF1518301
- CF1518302
- CF1518303
- CF1521101
- CF1521103
- CF1521102
- CF1521701
- CF1522306
- CF1522308
- CF1522307
- CF1523312
- CF1524407
- CF1525101
- CF1525103
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 Sets Recalled for Particulate Contamination
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- HighMoog Curlin Infusion Administration Set Recalled for Particulate Matter
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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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