Recall Z-2765-2017 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medtronic Perfusion Systems
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
| 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
| K900994 | ANTEGRADE/RETROGRADE Y W/INTEGRAL SELECTOR SWIT. Dlp, Inc., Aug 15, 1990 |