Z-0511-2021Class II

REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2...

Name: Z-0511-2021 REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2...
Creator: ICU Medical, Inc.
Published: 2020-07-01
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-07-01 / Terminated / root cause: design

FDA source

ICU Medical, Inc. began a recall of 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)... on 2020-07-01. FDA classified it as Class II and gives the reason as "Incorrect filter assemblies in IV administration set". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0511-2021
Classification: Class II
Status: Terminated
Initiated: 2020-07-01
Posted: 2020-12-01
Terminated: 2022-12-01
Recalling firm: Abbott Medical
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.
Product code: FMG Stopcock, I.V. Set
Reason for recall: Incorrect filter assemblies in IV administration set.
Root cause tag: design
FDA root cause: Component design/selection
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]. .
Quantity in commerce: 1100 units
Distribution: U.S. Nationwide distribution including in the states of WI, MA, CA, FL, MN, IL, NY.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0511-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0511-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-09	2020-12-01

Product code FMG

K964435Class IIPrimary IV SetIcu Medical, Inc. / cleared 1997-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)