CareFusion EnVe Ventilator, Model 19250-001. Manufactured by: CareFusion, 22745 Savi Ranch, Yorba Linda, CA 92887 USA. E
FDA device recall Z-0074-2012 · posted 2011-10-26 · Terminated
Recall details
- Recalling firm
- CareFusion 203, Inc.
- Reason for recall
- CareFusion has identified potential risks associated with the EnVe ventilator manufactured between December 2010 and May 2011. There are 3 issues that can result in ventilation delivery to the patient being interrupted. CareFusion will be contacting facilities to coordinate implementation of the necessary corrective actions.
- Action taken
- The firm, CareFusion, sent an "URGENT PRODUCT RECALL" letter dated September 12, 2011 to its customers.The letter identified affected product, described the 3 issues providing the description of the event, potential risk, and provided required action for Users. The letter also stated that CareFusion would be contacting the facility to coordinate the corrective action. If you have any questions and/or need support, please contact CareFusion Technical Support at 1-800-554-8933 from Mon. - Fri. 8:00am -5:00pm Pacific Time.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 128 units
- Distribution
- Nationwide distribution: USA including states of: CA, CO, FL, IL, MI, MN, MT, ND, NJ, NM, NY, OK, PA, TX, UT, WI, and WV.
- Date initiated
- 2011-09-12
- Date posted
- 2011-10-26
- Date terminated
- 2012-11-22
- Location
- Minneapolis, MN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PALMTOP VENTILATOR, MODELS PTV-8, PTV-10 (K070594) | Pulmonetic Systems, Inc. | 2007-08-01 |