FDA recall Z-2053-2019

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

Product

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.

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-2053-2019