Z-2622-2014Class I

98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item...

Name: Z-2622-2014 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item...
Creator: ICU Medical, Inc.
Published: 2014-08-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2014-08-19 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets... on 2014-08-19. FDA classified it as Class I and gives the reason as "ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2622-2014
Classification: Class I
Status: Terminated
Initiated: 2014-08-19
Posted: 2014-09-19
Terminated: 2014-11-18
Recalling firm: Abbott Medical
Product: 98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Product code: FMG Stopcock, I.V. Set
Reason for recall: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ICU Medical sent an Urgent Medical Device Recall letter dated August 19, 2014 to all affected customers. The letter identified the affected product, problems identified and the actions to be taken. Customers were instructed to complete the recall response form and fax to ICU Medical at (801) 264-1755 or by email: [email protected]. Customers with questions or require assistance relating to this recall were instructed to contact ICU Customer Service Monday through Friday between the hours of 8:30 AM and 4:00 PM Pacific time: 866-829-9025 and select option 8, or e-mail the following address: [email protected]. For questions regarding this recall call 801-264-1732.
Quantity in commerce: 1150 units
Distribution: Worldwide Distribution - US (nationwide) in the state of WA, OR and the country of South Africa.
Product codes and lots: Lot # 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2622-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2619-2014	Class I	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-19
Z-2620-2014	Class I	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-19
Z-2621-2014	Class I	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-19
Z-2622-2014	Class I	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-19

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)