FDA recall Z-2054-2019

Zevex Incorporated (dba MOOG Medical Devices Group) · Class II · 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.

Reason for recall

Administration sets leaked at the filter.

Distribution

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

Key facts

Status: Terminated
Initiation date: 2019-02-27
Report date: 2019-07-31
Termination date: 2021-04-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2054-2019