Pulmonetic Systems P/N 19189-001 Patient Circuit SPU W/O PEEP 15 FT 5/Pkg. These circuits are intended for use with the
FDA device recall Z-2205-2010 · posted 2010-08-10 · Terminated
Recall details
- Recalling firm
- CareFusion 203, Inc.
- 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
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 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.
- Date initiated
- 2010-07-02
- Date posted
- 2010-08-10
- Date terminated
- 2011-12-17
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR (K083688) | Pulmonetic Systems, Inc. | 2009-03-18 |