MOOG Curlin Infusion Administration Sets Recalled for Filter Leaks
Zevex Incorporated is recalling specific lots of MOOG Curlin Infusion Administration Sets because they leaked at the filter.
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 defect that compromises sterility and function, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Zevex Incorporated, doing business as MOOG Medical Devices Group, is recalling specific lots of MOOG Curlin Infusion Administration Sets. The affected product is the REF 340-4130-V model, which features non-DEHP tubing, a non-vented bag spike, and a vented 0.2 micron filter with an add-on check valve. The sets are packaged 20 per carton and are sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
The recall was initiated because the administration sets leaked at the filter. This defect could compromise the integrity of the sterile barrier or the delivery of the infusion. The affected lot numbers are CF1820216, CF1821617, CF1822214, and CF1823616, with UDI 38148440000471. A total of 756 20-set cases were distributed.
Distribution was made to Georgia, Illinois, Kansas, Massachusetts, Michigan, and Ohio. There was no foreign, military, or government distribution. Healthcare facilities and consumers who have these specific lots should stop using the product and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- MOOG Curlin Infusion Administration Set, REF 340-4130-V, Non-DEHP Tubing with Non-Vented Bag Spike and Vented 0.2 Micron Filter with add-on check valve, packaged 20 sets/carton, sterile. The firm name on the label is ZEVEX, Inc., Salt Lake City, UT.
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 (5)
- Lot numbers CF1820216
- CF1821617
- CF1822214
- and CF1823616
- UDI 38148440000471.
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 Set Recalled for Filter Leaks
FDA (Devices) · 2019-07-31
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