ICU Medical, Inc. REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle catheter (which is inserted into a vein). Directions for Use: icumedical IV Extensio Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Incorrect filter assemblies in IV administration set.

Recommended Action

Per FDA guidance

On 07/01/2020, the firm sent an Urgent: Medical Device Recall" to customers via mail, by third party to inform them that the firm has become aware that there is a potential problem related to the IV administration set with incorrect filter, which may result in delay in therapy, contamination or particulate embolism. This recall affected specific lots. The firm is instructing customers to discontinue the use, distribution and quarantine the products, print the return label from http://expertezlabel.com and return the affected devices to third party contracted service and if questions, to contact ProductComplaintsPP@icumed.com or 1-844-654-7780 for adverse event or complaints and for additional assistance, to call 1-866-829-9025, option 8 or customerservice@icumed.com. .