Zevex Incorporated (dba Moog Medical Medical Devices Group): MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, packaged 20/box, for use with t

Is my product affected?

MOOG Curlin Infusion Administration Set, Ref 340-4114, Non-DEHP Microbore Tubing with Non-Vented Bag Spike, 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

• UPC 38148440000396

Check against the official notice below — it lists the full affected range.

What happened

Zevex Incorporated (doing business as Moog Medical Medical Devices Group) is recalling its MOOG Curlin Infusion Administration Set (Reference 340-4114), a non-DEHP microbore tubing with non-vented bag spike packaged 20 sets per box. The recall affects 56,244 cases distributed nationwide in the United States, as well as to government, military, and foreign locations including Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia. The products have a UDI of 38148440000396 and include multiple lot and serial numbers ranging from CF1514701 through CF1616608.

The recall was initiated because particulate was found on the Curlin spike. The source document does not specify a remedy or corrective action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Particulate found on the Curlin spike.

Details from the source

Reason for recall: Particulate found on the Curlin spike. Distribution: Distribution was nationwide. There was government and military distribution. Foreign distribution was made to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia. Quantity: 56,244/20 administration set cases Lot/code info: UDI 38148440000396, Lot/serial numbers: CF1514703, CF1514702, CF1514702, CF1514701, CF1514702, CF1517405, CF1517406, CF1518301, CF1518302, CF1518303, CF1518301, CF1521101, CF1521103, CF1521102, CF1521701, CF1522306, CF1522308, CF1522307, CF1523312, CF1524407, CF1524407, CF1525101, CF1524407, CF1525103, CF1525102, CF1526505, CF1526506, CF1527307, CF1527306, CF1528011, CF1528607, CF1528606, CF1529306, CF1529307, CF1530106, CF1530707, CF1530706, CF1530706, CF1530705, CF1530706, CF1530707, CF1530706, CF1530707, CF1532102, CF1531406, CF1532102, CF1531405, CF1532975, CF1532976, CF1532976, CF1532976, CF1532976, CF1535001, CF1533504, CF1534902, CF1535666, CF1600507, CF1600508, CF1601203, CF1601903, CF1602604, CF1603304, CF1604704, CF1605406, CF1606104, CF1607504, CF1610405, CF1611003, CF1612404, CF1613105, CF1613804, CF1615209, CF1616608, and CF1616608.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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