Recall Z-2613-2026 ยท OEZ Cardiovascular Procedure Kit
Medline Industries, LP
Medline Convenience kits containing recalled Swan-Ganz Catheters CABG A CDS CDS982269K CDS982269L CDS982269M CDS982269N CARDIAC MAJOR DYNJ901328D DYNJ901328F HEART A DYNJ903465F DYNJ903465G HEART TRAY-VASCULAR DYNJ907857 DYNJ907857A DYNJ907857B KIT UNIVERSITY CABG PK DYNJ905857A OPEN HEART CDS981161AA CDS981161AB DYNJ905437A DYNJ909090 DYNJ909090C DYNJ9855016R D
| Date | Jun 26, 2026 (initiated May 28, 2026) |
| Status | Open, Classified |
| Reason | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on these catheters. This has led to instances of leakage, lumen damage, and breakage, and may lead to infection, medication loss, and/or blood loss. |
| Root cause | Process change control |
| Action | On May 28, 2026, the firm notified customers via letters titled "URGENT MEDICAL DEVICE CORRECTION." Customers were referred to BD's recall notice, which provides advice for users and instructions to mitigate hub breakage issues. Product return is not required. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
| Quantity | 9,272 kits |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, IL, MO, NJ, OH, OK, TN, TX, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.