FDA-Device2019-07-31Class II

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 intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Zevex Incorporated (dba MOOG Medical Devices Group)
Hazard

Administration sets leaked at the filter.

Sold states
Distribution was made to GA, IL, KS, MA, MI, and OH. There was no foreign/military/government distribution.
Affected count
569/20-set caess
Manufactured in
4314 S Zevex Park Ln, N/A, Salt Lake City, UT, United States
Products
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 intravenous, intra-arterial, epidural, subcutaneous, or enteral infusions.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2053-2019

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