Z-2054-2019 Class II Terminated

Recalled by Zevex Incorporated (dba MOOG Medical Devices Group) — Salt Lake City, UT

FDA device recall Z-2054-2019 was initiated by Zevex Incorporated (dba MOOG Medical Devices Group) on February 27, 2019 and is designated Class II. Reason for recall: Administration sets leaked at the filter. The recall status is terminated (terminated April 28, 2021). Affected quantity: 756/20-set cases.

Recall Details

Product Type
Devices
Report Date
July 31, 2019
Initiation Date
February 27, 2019
Termination Date
April 28, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
756/20-set cases

Product Description

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 Pattern

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

Code Information

Lot numbers CF1820216, CF1821617, CF1822214, and CF1823616, UDI 38148440000471.