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U.S. Department of Health and Human Services

Class 2 Device Recall Pulmonetic Systems

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  Class 2 Device Recall Pulmonetic Systems see related information
Date Initiated by Firm July 02, 2010
Date Posted August 10, 2010
Recall Status1 Terminated 3 on December 17, 2011
Recall Number Z-2205-2010
Recall Event ID 56201
510(K)Number K083688  
Product Classification ventilator, continuous, facility use - Product Code CBK
Product Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg.
These circuits are intended for use with the MR Conditional LTV 1200 System with the ventilator utilizing an external exhalation valve, as single patient use (SPU) only patient circuits for adult and pediatric patients. The LTV 1200 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support: -Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via mask). -Assist/Control, SIMV, CPAP or NPPV modes of ventilation. -Breath types including Volume, Pressure Control and Pressure Support.
Code Information Y09D1922 Y09H0564 Y09H0565 Y09K0491 Y09K0492 Y09S1283 Y09S1284 Y10A1230
Recalling Firm/
Manufacturer		 CareFusion 203, Inc.
17400 Medina Rd Ste 100
Minneapolis MN 55447-1341
For Additional Information Contact
763-398-8300
Manufacturer Reason
for Recall		 CareFusion is recalling the P/N 19189-001 Patient Circuit (SPU W/O PEEP 15ft) because some of the circuit sense lines may have been reversed during the manufacturing process. If the sense lines have been reversed, immediately upon connection of the patient circuit to the ventilator and turning the ventilator on, the ventilator will begin to autocycle (with increased pressure delivered) with both
FDA Determined
Cause 2		 Process control
Action Customers were sent a CareFusion "Urgent Medical Device Recall Notification" dated July 2, 1010. The letter was addressed to Respiratory Care Manger. The letter described the product , problem and advised consignees to remove the affected product from inventory and promptly return it to CareFusion for replacement. Please contact CareFusion Technical Support at 800-754-1914, option 2, upon receipt of this notification to arrange for prompt return and replacement of any the patient circuits in your inventory.
Quantity in Commerce 200 boxes (5 each)
Distribution Nationwide distribution: AL, CA, FL, GA, HI, IL, IN, KS, MA,MI, MN, MT, NJ, NY, NC, OR, PA, RI, TN, TX, UT, VA, WA, and WI.
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 = CBK and Original Applicant = PULMONETIC SYSTEMS, INC.
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