FDA Device

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

Hazard

Incorrect filter assemblies in IV administration set.

What You Should Do

Remedy

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. .

Products

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 intravasc
Brand
ICU Medical, Inc.
UPC
Product code : MC330209; Lot numbers:4447222, 4536285, 4572773, 4603405 Unique Device Identifier (UDI)s: (01)10887709080543(17)241101(30)50(10)4447222; (01)10887709080543(17)241201(30)50(10)4536285; (01)10887709080543(17)250101(30)50(10)4572773; (01)10887709080543(17)250101(30)50(10)4603405

Units Affected

1100 units