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U.S. Department of Health and Human Services

Class 2 Device Recall CelluTome

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 Class 2 Device Recall CelluTomesee related information
Date Initiated by FirmNovember 19, 2014
Date PostedJanuary 07, 2015
Recall Status1 Terminated 3 on September 18, 2015
Recall NumberZ-0933-2015
Recall Event ID 69961
Product Classification Dermatome - Product Code GFD
ProductCelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI USA, Inc. Part Number CT-H50 or CT-H25 The CelluTome Epidermal Harvesting System is intended to reproducibly cut a thin skin graft for autologous skin grafting.
Code Information CT-H25 lot numbers: 3249980000, 3249990000, 3250010000, 2537872, 2556866; CT-H50 lot numbers: 3249660000, 3249840000, 3250050000, 2498886, 2510874, 2537879, 2545871
Recalling Firm/
Manufacturer		 KCI USA, INC.
12930 IH 10 West
San Antonio TX 78249
For Additional Information Contact
210-515-4108
Manufacturer Reason
for Recall		KCI has received reports that, in a small number of cases, the CelluTome Harvester (a component of the CelluTome Epidermal Harvesting System), blades have the potential to drift during shipping and could prematurely protrude into openings of harvester top plate.
FDA Determined
Cause 2		Device Design
ActionKCI sent an Urgent - Voluntary Medical Device Field Notification letter to all affected consignees on December 8, 2014. The letter notified the customer of the issue, and provided instructions to inspect their harvester prior to use. If blade drift is identified, instructionswere provided to the customer to either return the device to KCI, or if they wish, how to reset the blade prior to use. The letter instructs the customer to respond to the recall notifcation by returning the product reconciliation form attached the letter. Follow-up notifcations will be send to non-responding consignees. Consignees with questions were instructed to contact their local KCI Representative or Customer Technical Service Center at 1-800-275-4524 and select option 3. For questions regarding this recall call 210-515-4108.
Quantity in Commerce1,139/5 Packs
DistributionWorldwide Distribution - USA (Nationwide) and Internationally to Australia, Austria, Canada, France, Germany, Ireland, Italy, Isreal, Netherlands, South Africa, Spain, Sweden, Switerland, Turkey, UAE, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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