Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to trans
FDA device recall Z-0160-2011 · posted 2010-10-28 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences, Llc
- Reason for recall
- The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated.
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- DXG
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution - USA including CA, PA, and MI and the countries of Switzerland and Thailand
- Date initiated
- 2010-06-25
- Date posted
- 2010-10-28
- Date terminated
- 2011-05-24
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER (K060660) | Edwards Lifesciences, LLC | 2006-04-25 |