Zevex Incorporated (dba Moog Medical Medical Devices Group): MOOG Curlin Infusion Administration Set, Ref 340-4133, Non-DEHP Microbore Tubing with Non-Vented Bag Spike and Needleless Injection Port (P

Is my product affected?

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 w

• UPC 38148440000488

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

What happened

Zevex Incorporated is recalling MOOG Curlin Infusion Administration Sets (Ref 340-4133) due to particulate found on the Curlin spike. The affected product is a non-DEHP microbore tubing set with a non-vented bag spike and needleless injection port. A total of 756 cases of 20-administration set units were distributed, identified by UDI 38148440000488 and lot/serial numbers CF1519507, CF1522502, CF1524406, and CF1528008.

The recalled product was distributed nationwide in the United States, including to government and military facilities, as well as internationally to Canada, Saudi Arabia, Turkey, Croatia, United Arab Emirates, and Australia. The recall notice does not specify what actions affected consumers should take.

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: 756/20-administration set cases Lot/code info: UDI 38148440000488, Lot/serial numbers: CF1519507, CF1522502, CF1524406, and CF1528008.

Source

Official record: FDA (Device enforcement) ↗

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

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