Moog Curlin Infusion Administration Set Recalled Due to Particulate Matter
Zevex Incorporated is recalling specific lots of Moog Curlin Infusion Administration Sets because particulate matter was 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 have been 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. 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 involves 2,497 cases, each containing 20 administration sets. The affected lot numbers are CF1518304, CF1521104, CF1524301, CF1523803, CF1528603, and CF1613101. The UDI for the product is 38148440000495. 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 the affected administration sets immediately. Users should check their inventory for the specific lot numbers listed above and contact the manufacturer or their supplier for further instructions on returning or replacing the product.
The recalled product
- Product
- MOOG Curlin Infusion Administration Set, Ref 340-4134, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Y-Site with Check Valve, packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, Sterile. Product Usage: Administration set to be…
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 (7)
- UDI 38148440000495
- Lot/serial numbers: CF1518304
- CF1521104
- CF1524301
- CF1523803
- CF1528603
- and CF1613101.
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
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