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.

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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