Recall Z-2776-2015 ยท DXO Transducer, Pressure, Catheter Tip
Edward Lifesciences, Llc
Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, intracranial, or intrauterine pressure monitoring.
| Date | Sep 16, 2015 (initiated Jul 31, 2015) |
| Status | Terminated |
| Reason | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. |
| Root cause | Device Design |
| Action | Edwards sent an Urgent Product Recall Letter on August 10, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The firm's letter requests that customers return any of the units that they currently have in inventory. The letter requests that customers verify the inventory that has been pre-populated on the acknowledgment form, and complete the remainder of the form. The firm states to fax back the acknowledgment form within three days of receipt of notification to Edwards Customer Service at 1-800-422-9329. The firm |
| Quantity | 13,077 (U.S.) and 12,306 (International) |
| Distribution | Worldwide Distribution - US nationwide, Australia, Austria, Canada, China, Colombia, Croatia, Denmark, France, Germany, Great Britain, Italy, Netherlands, New Zealand, Sweden, and Slovenia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142749 | TruWave Disposable Pressure Transducer Edwards Lifesciences, LLC, Jan 18, 2015 |