Z-2053-2019 Class II Terminated

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

FDA device recall Z-2053-2019 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: 569/20-set caess.

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
569/20-set caess

Product Description

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 Pattern

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

Code Information

Lot numbers CF1819415, CF1820215, CF1821616, CF1822914, and CF1823615, UDI 38148440000464.