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Recall Observatory FDA recall evidence

Device 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.

Z-2054-2019

February 27, 2019

Class II

Product summary

Firm
Zevex Incorporated (dba MOOG Medical Devices Group)
Event
Event 82864
Status
Terminated
Classification
Class II
Quantity
756/20-set cases
Official record key
device-enforcement:Z-2054-2019

Official wording

Reason: Administration sets leaked at the filter.

Code information: Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.

Distribution pattern: Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Administration sets leaked at the filter.