FDA Device recall Z-2941-2018
DUO FLOW CUSTOM TRAYS
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of DUO FLOW CUSTOM TRAYS by Medical Components, citing the suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 b….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2941-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-12 |
| Published | 2018-09-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medical Components |
| Distribution | US |
Product
DUO FLOW CUSTOM TRAYS; TRAY #414 TRAY #415 TRAY #67
Reason
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
Identifiers
| code_info | MCBC900 MCBP350 MCDC900 MCGA140 MCCD760 MKAL320 MCAS020 MCCF310 MCCV750 MCCV870 MCDL720 MCDV440 MCFJ760 MKAF680 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2941-2018%22
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