CLASS II Device recall · Reported 5 Sep 2018 · FDA Enforcement Report
Duo-Flow IJ Full Tray recalled by Medical Components
Medical Components is recalling Duo-Flow IJ Full 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-2935-2018
- 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
- Other Medical 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
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
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?
MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO MCBN350 MCBY390 MCCV240 MCDA860 MCDG370 MCDJ730 MCDP710 MCFA850 MCFB360 MCFD630 MCFM700 MCFS710 MCFX790 MKAD790 MKAG470 MKAT090 MKAX630 MCBA820 MCBYS20 MCCP980 MCFD640 MCFQ350 MKAR100 MCAC610 MCAT590 MCCH750 MCDQ920 MCFV690 MCAH750 MCFZ550
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 80581This product is part of a recall event; the main page for the event is Soft-line Duo-flow Double Lumen Catheter/catheter Set recalled.
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