Z-0698-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 7, 2018
Initiation Date
November 10, 2017
Termination Date
December 12, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
756/20-administration set cases

Product Description

MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (Positive Pressure), packaged 20/box, for use with the Moog Curlin Ambulatory Volumetric Infusion Pump, RX, 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

Particulate found on the Curlin spike.

Distribution Pattern

Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia.

Code Information

UDI 38148440000488, Lot/serial numbers: CF1519507, CF1522502, CF1524406, and CF1528008.