Recall Z-2205-2010 ยท CBK Ventilator, Continuous, Facility Use
CareFusion 203, Inc.
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 car
| Date | Aug 10, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083688 | PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR Pulmonetic Systems, Inc., Mar 18, 2009 |