Class 2 Device Recall Pulsiocath PiCCO ProAQT Monitoring Kit

• Date Initiated by Firm: November 04, 2014
• Date Posted: February 17, 2015
• Recall Status: Terminated 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
• FEI Number: 3010289715
• 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: 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