CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Soft-line Duo-flow Double Lumen Catheter Tray recalled
Medical Components is recalling Soft-line Duo-flow Double Lumen Catheter Tray, 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-2939-2018
- 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 TRAY; T3500 T4000 T4400 T4424
Where it was distributed
Nationwide distribution; worldwide distribution.
Questions about this recall
Is Soft-line Duo-flow Double Lumen Catheter Tray recalled?
Yes. Medical Components recalled Soft-line Duo-flow Double Lumen Catheter Tray on 12 Jul 2018. The recall is Class II and its status is Terminated. Recall number Z-2939-2018.
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?
MCBH160 MCCJ940 MKAG230 MKAS240 MBZV560 MCAR110 MCBM700 MCBZ130 MCCK670 MCCV840 MCDC320 MCDH160 MCDP900 MCFB210 MCFN490 MCFP330 MCFQ160 MCFX190 MKAF070 MKAJ840 MKAS430 MKAZ840 MBZB490 MCAD070 MCBB940 MCBH000 MCBN030 MCBT690 MCCK250 MCCP870 MCDK690 MCDP260 MCFG470 MCFV940 MKAF420 MKAJ850 MKAP270 MKAT230 MCAK690 MCBD150
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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