Z-2001-2020Class II

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right...

Name: Z-2001-2020 Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right...
Creator: ICU Medical, Inc.
Published: 2020-01-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2020-01-02 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge... on 2020-01-02. FDA classified it as Class II and gives the reason as "Inability for the guidewire to pass through the needles included with the catheter kits". 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-2001-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-02
Posted: 2020-05-14
Terminated: 2022-09-14
Recalling firm: Abbott Medical
Product: Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 41414-23
Product code: DQE Catheter, Oximeter, Fiber-Optic
Reason for recall: Inability for the guidewire to pass through the needles included with the catheter kits.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check. On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record.
Quantity in commerce: 235
Distribution: US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.
Product codes and lots: LOT Number/ UDI - 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2001-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1996-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1997-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1998-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-1999-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-2000-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-2001-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14
Z-2002-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-20	2020-05-14

Product code DQE

K091268Class IIHospira Latex-Free Critical Care and Advanced Sensor CathetersHospira, Inc. / cleared 2009-09-18

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)