FDAClass IIOctober 8, 2014

CelluTome Epidermal Harvesting System recall

CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50

Why was CelluTome Epidermal Harvesting System recalled?

Blade can shift during shipping which makes the product ineffective.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models 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.

Product
CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Recalling firm
KCI USA, Inc.
Quantity
1,331 units
Distribution
US nationwide Distribution
Recall date
October 8, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls