Recall Z-0160-2011
Edwards Lifesciences, Llc · initiated June 25, 2010
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.
Codes / lots: Lot Numbers: 58822824; 58821774
Reason for recall
The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
FDA-determined cause: Process design
Action taken
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.
Details
- Recall number
- Z-0160-2011
- Initiated
- June 25, 2010
- Posted by FDA
- October 28, 2010
- Terminated
- May 24, 2011
- Product code
- DXG – Computer, Diagnostic, Pre-Programmed, Single-Function
- Quantity
- 20 units
- Distribution
- Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
- Recalling firm
- Edwards Lifesciences, Llc, Irvine, CA