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Terminated

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 Recall Z-0511-2021 · Posted None

Recalling FirmICU Medical, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2020-07-01
Date Terminated2022-12-01
Product Quantity1100 units

Reason for Recall

Incorrect filter assemblies in IV administration set.

Firm Action

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 [email protected] or 1-844-654-7780 for adverse event or complaints and for additional assistance, to call 1-866-829-9025, option 8 or [email protected]. .

Root Cause

Component design/selection

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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