FDA Medical Device Recalls (openFDA)
Pulsion Medical Inc: 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.
- Recall number
- Z-1121-2015
- 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.
- Status
- Terminated
- Initiated
- 2014-11-04
- Posted
- 2015-02-17
- Terminated
- 2015-10-02
- Reason
- Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
- 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
- 90 units
- Distribution
- US Nationwide Distribution in the states of CT, NJ and NY. The affected product was distributed to one government consignee.
- Lot, serial or model codes
- Model Number PV8810US; Lot # 14AK20 and 14EK20
- 510(k) numbers
- ["K991886"]
- PMA numbers
- not on file
- Product code
- KRB
- Firm FEI
- 3010289715
- Firm city
- Powell
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28