Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CelluTome

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall CelluTome see related information
Date Initiated by Firm May 19, 2014
Date Posted September 29, 2014
Recall Status1 Terminated 3 on September 18, 2015
Recall Number Z-2717-2014
Recall Event ID 68329
Product Classification Dermatome - Product Code GFD
Product CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50
Code Information 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.
Recalling Firm/
Manufacturer		 KCI USA, Inc.
6203 Farinon Dr
San Antonio TX 78249-3441
For Additional Information Contact Steven Jackson
800-275-4524 Ext. 3
Manufacturer Reason
for Recall		 Blade can shift during shipping which makes the product ineffective.
FDA Determined
Cause 2		 Device Design
Action KCI sent an Urgent - Voluntary Medical Device Field Notification letter dated June 6, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The firm is sending Field Notifications to affected customers instructing them to complete appropriate actions. Option I: Contact your local KCI Representative or KCI Customer Technical Support at 1-800-275-4524 and select Option 3 to arrange for return and replacement of the affected harvester(s). Option 2: If you prefer, you may re-set the blade after removal from the packaging by gently tapping the curved end of the harvester against the palm of your hand, as shown in Figure 3, until the blade is no longer visible in the harvester top plate, as shown in Figure 4.
Quantity in Commerce 1,331 units
Distribution US nationwide Distribution
Total Product Life Cycle TPLC 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.
-
-