Recall Z-1715-2018 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
Datascope Corporation
BEQ-TOP 24202 ADULT ECC, Catalog No. 701054295
| Date | Oct 19, 2017 |
| Status | Terminated |
| Reason | The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse the balloon. This may increase resistance to flow in the venous line and cause a drop in ECMO circuit blood flow. |
| Root cause | Process control |
| Action | Affected consignees were notified by letter delivered via FedEx on October 19, 2017. After CTI expanded their recall in March 2018, Getinge accordingly alerted additionally affected consignees by letter delivered via FedEx on April 5, 2018. The recall letter advised customers of the issue and referenced the CTI recall notification, which was included as an attachment to Getinge's communication. End-users were instructed to examine their inventory to determine if they had any of the affected catalog/lot numbers. Any affected product is to be immediately quarantined and returned to Getinge by c |
| Quantity | 9 |
| Distribution | Distributed to accounts in AL, AR, CA, DC, FL, IL, LA, MO, NC, PA, SC, TX, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080592 | HLM TUBING SET WITH BIOLINE COATING Maquet Cardiopulmonary, AG, Sep 11, 2008 |