Recall Z-2768-2017 ยท DXS Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Medtronic Perfusion Systems
DLP Pressure Disposable Pressure Display Sets Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
| Date | Jul 10, 2017 (initiated Jun 22, 2017) |
| Status | Terminated |
| Reason | Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. |
| Root cause | Packaging process control |
| Action | Medtronic sent an Urgent Medical Device Recall letter dated June 22, 2017, to all affected consignees, both in the US, via 2-Day UPS Mail, and OUS, via local methods. Consignees were asked to quarantine and return any affected product. No recommendations were made for patients who have undergone procedures using affected product. US consignees were asked to complete and return a recall notification confirmation certificate to fax 651-367-0612, indicating that they were informed of the recall and executed the appropriate action. Customers with questions were instructed to contact Customer Serv |
| Quantity | 63053 (48180 US) (14873 OUS) |
| Distribution | Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K852232 | PRESSURE DISPLAY BOX #60000/TUBING SET #61000 Dlp, Inc., Aug 9, 1985 |