Recalls / —
—#92746
Product
Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series or compatible Edwards monitoring systems. This cable has instrument specific connectors.
- FDA product code
- DXG — Computer, Diagnostic, Pre-Programmed, Single-Function
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K060660
- Affected lot / code info
- Lot Numbers: 58822824; 58821774
Why it was recalled
The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
Root cause (FDA determination)
Process design
Action the firm took
Edwards Lifesciences contacted customers via telephone on June 22, 2010 informing them of the product, the problem and the action they should take. Customers were asked to locate their cables and send them back overnight using the provided Edwards FedEx account number. Edwards Lifesciences indicated their personnel would follow-up with each customer until all units were returned. For any questions regarding this recall call (949) 250-2007.
Recalling firm
- Firm
- Edwards Lifesciences, Llc
- Address
- 1 Edwards Way, Irvine, California 92614-5688
Distribution
- Distribution pattern
- Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
Timeline
- Recall initiated
- 2010-06-25
- Posted by FDA
- 2010-10-28
- Terminated
- 2011-05-24
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #92746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.