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U.S. Department of Health and Human Services

Class 2 Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit

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  Class 2 Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit see related information
Date Initiated by Firm November 04, 2014
Date Posted February 17, 2015
Recall Status1 Terminated 3 on October 02, 2015
Recall Number Z-1121-2015
Recall Event ID 69782
510(K)Number K991886  
Product Classification Probe, thermodilution - Product Code KRB
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.
Code Information Model Number PV8810US; Lot # 14AK20 and 14EK20
Recalling Firm/
Manufacturer		 Pulsion Medical Inc
3781 Attucks Dr
Powell OH 43065-6080
For Additional Information Contact Michael J. Barilla
214-446-8500 Ext. 101
Manufacturer Reason
for Recall		 Internal testing and investigation of the packaging revealed cracks and holes in primary packaging
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KRB and Original Applicant = PULSION MEDICAL SYSTEMS, INC.
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