MOOG Curlin Infusion Administration Set Recalled for Filter Leaks
Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets because they leaked at the filter. The affected sterile sets were distributed to six US states.
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 used for infusions that has a functional defect (leaking at the filter). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zevex Incorporated (dba MOOG Medical Devices Group) is recalling MOOG Curlin Infusion Administration Sets, REF 340-4130. The recall involves 569 20-set cartons of the sterile administration sets, which are used with the Moog Curlin Infusion Pump for intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.
The recall was initiated because the administration sets leaked at the filter. The affected lot numbers are CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, with UDI 38148440000464. Distribution was made to Georgia, Illinois, Kansas, Massachusetts, Michigan, and Ohio. There was no foreign, military, or government distribution.
Healthcare facilities and consumers should stop using the affected infusion administration sets and contact Zevex Incorporated for further instructions or a replacement.
The recalled product
- Product
- MOOG Curlin Infusion Administration Set, REF 340-4130, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter, packaged 20 sets/carton, sterile. Product Usage: Administration set to be used with the Moog Curlin Infusion Pump. The pump can be used for…
- 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 (6)
- Lot numbers CF1819415
- CF1820215
- CF1821616
- CF1822914
- and CF1823615
- UDI 38148440000464.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zevex Incorporated (dba MOOG 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 2 products in this recall →Related recalls
Same manufacturer · Zevex Incorporated (dba MOOG Medical Devices Group)
See all →- HighMOOG Curlin Infusion Administration Sets Recalled for Filter Leaks
FDA (Devices) · 2019-07-31
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