CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Soft-line Duo-flow Double Lumen Catheter/catheter Set recalled
Medical Components is recalling Soft-line Duo-flow Double Lumen Catheter/catheter Set, distributed nationwide in the US. The recall was initiated on 12 Jul 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2940-2018
- FDA event ID
- 80581
- Recalling firm
- Medical Components, Harleysville, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jul 2018
- FDA classified
- 25 Aug 2018
- Reported
- 5 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 12 Jul 2018 | Recall initiated by company | |
| 25 Aug 2018 | Classified by FDA | +44 days |
| 5 Sep 2018 | Published in enforcement report | +11 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Where it was distributed
Nationwide distribution; worldwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
MCDA290 MHLQ370 MHMZ270 MHSN190 MHTH950 MHTR800 MHXL900 MJAT510 MJAZ020 MJBL200 MJCV760 MJFP340 MJGC620 MJGX680 MJKN210 MJLP090 MLDF860 MHLL060 MHND620 MHPA230 MHQZ510 MHSR590 MHXJ990 MHYS090 MJDW030 MJGK930 MJGX690 MJJF710 MLBA570 MLBK460 MLCT650 MHKJ180 MHMJ970 MHPK440 MHRN870 MJBP190 MJHJ860 MLBG870
Where was it sold?
Nationwide distribution; worldwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 80581More recalls from Medical Components
All 38| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Power Injectable CT Port insertion kits recalled by Medical Components | Medical Components | Packaging Defects | Nationwide |
| Device | CLASS II | Medcomp 15.SF Titan HD Catheter (Cuff From Tip) recalled | Medical Components | Packaging Defects | 12 states |
| Device | CLASS II | C3 Wave App, v recalled by Medical Components | Medical Components | Device Malfunction | 13 states |
| Device | CLASS II | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled | Medical Components | Packaging Defects | Nationwide |
| Device | CLASS II | 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits recalled | Medical Components | Packaging Defects | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |