Z-1121-2015Class II

Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic...

Name: Z-1121-2015 Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic...
Creator: Pulsion Medical Inc
Published: 2014-11-04
License: https://open.fda.gov/license/

Pulsion Medical Inc / initiated 2014-11-04 / Terminated / root cause: packaging

FDA source

Pulsion Medical Inc began a recall of Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac... on 2014-11-04. FDA classified it as Class II and gives the reason as "Internal testing and investigation of the packaging revealed cracks and holes in primary packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1121-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-04
Posted: 2015-02-17
Terminated: 2015-10-02
Recalling firm: Pulsion Medical Inc
Product: Pulsiocath PiCCO ProAQT Monitoring Kit, single-use cardiac output (CO) sensor, one unit per plastic sterilizable package. Product Usage: Measures cardiac output by the thermodilution method, measurement of arterial blood pressure, and for cardiac output determination by arterial pulse contour analysis.
Product code: KRB Probe, Thermodilution
Reason for recall: Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
Root cause tag: packaging
FDA root cause: Packaging
Action: Pulsion sent an Urgent Medical Device Recall notification letter on 11/04/14 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers where instructed to: " Piease examine your inventory immediately to determine if you have any of the products listed. " lf so, please remove the affected products; quarantine them in a secure location. " Piease complete and return the enclosed Field Recall Response Form, acknowleding your receipt and understanding of this communication " Send all affected products back to PULSION Medical Systems. " Upon return of the affected product you will receive a credit note. For questions contact your PULSION Medical lnc Recall Coordinator.
Quantity in commerce: 90 units
Distribution: US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
Product codes and lots: Model Number PV8810US; Lot # 14AK20 and 14EK20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1121-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1121-2015	Class II	Terminated	Voluntary: Firm initiated	2015-02-25	2015-02-17

Product code KRB

K991886Class IIPulsion Pulsiocath, Pulsion Pcco Monitoring Kit, Pulsion in-Line Injectate SensorPulsion Medical Systems, Inc. / cleared 2000-05-11

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)