FDA Device recall Z-2937-2018
Duo-Flow XTP Straight Full Set, RMS02105 RMS02108
- FDA Device
- Class II
- terminated
- Published 2018-09-05
On 2018-09-05 the FDA classified a Class II recall of Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 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-2937-2018 |
| 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 XTP Straight Full Set, RMS02105 RMS02108
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 | MKAC440 MCCH440 |
|---|
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-2937-2018%22
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