CLASS II ONGOING Device recall · Reported 17 Apr 2024 · FDA Enforcement Report
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. recalled
ConvaTec is recalling ConvaTec CarboFlex, distributed nationwide in the US. The recall was initiated on 27 Feb 2024 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-1495-2024
- FDA event ID
- 94148
- Recalling firm
- ConvaTec, Greensboro, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Feb 2024
- FDA classified
- 8 Apr 2024
- Reported
- 17 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 27 Feb 2024 | Recall initiated by company | |
| 8 Apr 2024 | Classified by FDA | +41 days |
| 17 Apr 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The product does not meet sterility assurance level.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5 packages/market unit.
Where it was distributed
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
Nationwide CaliforniaMissouriNew MexicoPennsylvaniaTexasWashington
Questions about this recall
Is ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204 recalled?
Yes. ConvaTec recalled ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204 on 27 Feb 2024. The recall is Class II and its status is Ongoing. Recall number Z-1495-2024.
Why was it recalled?
The product does not meet sterility assurance level.
Which lots are affected?
Order #403204 - Lot numbers 3J00675, 3J02320, 3J02332, 3L04811, and 4A00343.
Where was it sold?
US Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.
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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