CLASS II Device recall · Reported 8 Oct 2014 · FDA Enforcement Report
CelluTome Epidermal Harvesting System recalled by Kci Usa
KCI USA is recalling CelluTome Epidermal Harvesting System, distributed nationwide in the US. The recall was initiated on 19 May 2014 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-2717-2014
- FDA event ID
- 68329
- Recalling firm
- KCI USA, San Antonio, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2014
- FDA classified
- 29 Sep 2014
- Reported
- 8 Oct 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 19 May 2014 | Recall initiated by company | |
| 29 Sep 2014 | Classified by FDA | +133 days |
| 8 Oct 2014 | 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
Blade can shift during shipping which makes the product ineffective.
Product as listed by the FDA
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Where it was distributed
US nationwide Distribution
Questions about this recall
Why was it recalled?
Blade can shift during shipping which makes the product ineffective.
Which lots are affected?
Part number CT-H25 with the following lot numbers: 3244680000, 3446210000, 3246280000, 3246480000, 3246490000, 3246970000, 3247020000, 3247030000, 3247130000, 3247440000, 3247670000, 3247680000, 3247980000, 3248070000, 3248200000, 3248300000, 3249120000, 3249130000, 3249140000, 3249150000, 3249160000. Part number CT-H50 with the following lot numbers: 324782, 324796, 324797, 3245120000, 3245670000, 3245680000, 3246270000, 3246490000, 3246690000, 3246700000, 3246940000, 3246980000, 3247140000, 3247160000, 3247170000, 3247250000, 3247310000, 3247470000, 324780000, 3247810000, 3247820000, 3247960000, 3247970000, 3248080000, 3248190000, 3248230000, 3248300000, 3248380000, 3248960000, 3248970000, 3248980000, 3248990000, 3249000000, 3249010000, 3249020000, 3249030000, 3249040000, 3249050000, 3249060000, 3249070000, 3249080000, 3249090000, 3249100000, 3249110000, 3249390000, 3249580000.
Where was it sold?
US nationwide 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.
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