Z-2129-2012Class II

Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets

Name: Z-2129-2012 Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets
Creator: ICU Medical, Inc.
Published: 2012-04-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-04-17 / Terminated / root cause: manufacturing process

FDA source

ICU Medical, Inc. began a recall of Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment on 2012-04-17. FDA classified it as Class II and gives the reason as "The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded". 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-2129-2012
Classification: Class II
Status: Terminated
Initiated: 2012-04-17
Posted: 2012-08-02
Terminated: 2012-08-23
Recalling firm: Abbott Medical
Product: Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: ICU Medical sent an Urgent Medical Device Recall letter dated April 2012 to all affected customers. The letter identified the recalled product, problem and actions to be taken. Customers were instructed to inspect inventory, destroy affected products according to hospital protocol, complete and return verification form and contact ICU Customer Service to order replacement products. The letter states that ICU Medical will credit customer for any product destroyed once the completed verification form is received. This recall should be carried out to the user level and passed on to all those who need to be aware within your organization or any other organization the device may have been transferred to. Should you have any questions or require assistance relating to this recall please 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]
Distribution: Nationwide distribution
Product codes and lots: Part Number 460730418 510(k) K052865 Lot number 2444750

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2129-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2128-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02
Z-2129-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02
Z-2130-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02
Z-2131-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-02

Product code DQO

K052865Class IIHospira Cath Lab Convenience KitsIcu Medical, Inc. / cleared 2005-12-22

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)