Z-0069-2019Class II

ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular...

Name: Z-0069-2019 ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular...
Creator: ICU Medical, Inc.
Published: 2018-08-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-08-20 / Completed / root cause: design

FDA source

ICU Medical, Inc. began a recall of ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 The Intravascular Administration Set is a single use, sterile... on 2018-08-20. FDA classified it as Class II and gives the reason as "Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as design.

Recall record

Recall number: Z-0069-2019
Classification: Class II
Status: Completed
Initiated: 2018-08-20
Posted: 2018-10-04
Recalling firm: Abbott Medical
Product: ICU Medical 14" (36 cm) Appx 3.6 ml, Bifuse Transfer Set w/Rotating Luer, REF: 14237-28 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 or catheter (which is inserted into a vein).
Product code: FMG Stopcock, I.V. Set
Reason for recall: Design change implemented changing the device from a blood set with a filter to a transfer set without a filter. Both devices had the same listing number. Customers may not be aware of the product design change and use the transfer set as a blood transfusion set without realizing a blood filter is not included.
Root cause tag: design
FDA root cause: Device Design
Action: On 08/20/18, the firm, icumedical, mailed "URGENT MEDICAL DEVICE RECALL" l notices to consignees. The notice described the product, problem and actions to be taken. If product has been further distributed, the firm requested consignees to notify users. Customers were advised to return affected product only if the blood filter is needed. Customers needing response forms and/or return labels were advised to call 1-800-479-0551. For further inquiries call: 1-866-829-9025.
Quantity in commerce: 2361 Units
Distribution: U.S. Distribution in states of: NY, AL, CA, MS, PA, GA, MI, NC, WI, IL, WA, UT and FL.
Product codes and lots: lots: 85-540-SJ, 86-189-SL, 86-911-SJ

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0069-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0069-2019	Class II	Completed	Voluntary: Firm initiated	2018-10-10	2018-10-04

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)