—#182611

Product

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 Extension Sets Clave/MicroClave/NanoClave Connectors Antimicrobial Clave/MicroClave Connectors Spiros Closed Male Luer.

FDA product code: FMG — Stopcock, I.V. Set
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K964435
Affected lot / code info: 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

Why it was recalled

Incorrect filter assemblies in IV administration set.

Root cause (FDA determination)

Component design/selection

Action the firm took

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. .

Recalling firm

Firm: ICU Medical, Inc.
Address: 951 Calle, Amanecer San Clemente, California 92673-6212

Distribution

Distribution pattern: U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.

Timeline

Recall initiated: 2020-07-01
Terminated: 2022-12-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.