Cardinal Health EnVe Ventilator Cat # 19250-001, Manufactured by Cardinal Health, Minneapolis, MN 55447-1341. Intended t
FDA device recall Z-0857-2010 · posted 2010-02-25 · Terminated
Recall details
- Recalling firm
- CareFusion 203, Inc.
- Reason for recall
- CareFusion is recalling the EnVe Ventilator because the EnVe Ventilator does not fully meet applicable standards for immunity to electro-Magnetic Interference (EMI) when tested in the laboratory environment. CareFusion has identified certain device malfunctions that may affect device performance and patient safety in the intended use environment.
- Action taken
- CareFusion issued an "Urgent Medical Device Recall notification" letter dated January 07, 2010. The letter was addressed to the Director of Respiratory Care describing the problem and the product. Consignees were told that a Service Representative will contact them to arrange for the prompt return of the affected product for correction. For further information, contact CareFusion Technical Support at 1-800-231-2446, Option 1.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CBK
- Quantity affected
- 9
- Distribution
- MN
- Date initiated
- 2010-01-08
- Date posted
- 2010-02-25
- Date terminated
- 2011-12-17
- 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 |