KCI CelluTome Epidermal Harvesting System Recalled Due to Blade Shift
KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System because the blade can shift during shipping, rendering the product ineffective.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to product ineffectiveness due to mechanical shifting during shipping, with no reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
KCI USA, Inc. is recalling 1,331 units of the CelluTome Epidermal Harvesting System, specifically Part numbers CT-H25 and CT-H50. The recall was initiated because the blade can shift during shipping, which makes the product ineffective.
The affected products were distributed nationwide in the United States. The recall covers specific lot numbers for both part numbers, including 3244680000, 3446210000, and 324782, among others.
Consumers and healthcare providers should stop using the affected units and contact KCI USA, Inc. for instructions on return or replacement. No injuries or illnesses have been reported in connection with this recall.
The recalled product
- Product
- CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
- Manufacturer
- KCI USA, Inc.
- Hazard
- Affected units
- 1,331
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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