FDA Device recall Z-2608-2026
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
- FDA Device
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407 by Medline Industries, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2608-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-28 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience kits containing recalled Swan-Ganz Catheters CENTRAL AND ARTERIAL LINE TOTE DYNJ8407
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.
Identifiers
| code_info | UDI-DI 10198459704543 Lot 26DBB599 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2608-2026%22
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