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U.S. Department of Health and Human Services

Class 2 Device Recall Hand Foot II

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  Class 2 Device Recall Hand Foot II see related information
Date Initiated by Firm January 27, 2017
Date Posted March 20, 2017
Recall Status1 Terminated 3 on February 08, 2019
Recall Number Z-1683-2017
Recall Event ID 76725
510(K)Number K872604  
Product Classification Light, ultraviolet, dermatological - Product Code FTC
Product Hand Foot II, UVB-138. One device per box; device is surrounded by foam inserts inside a corrugated box. For UV phototherapy treatment.
Code Information Serial numbers: 39870, 39873, 39874, 39866, 39867, 39871, 39869
Recalling Firm/
Manufacturer		 National Biological Corp
23700 Mercantile Rd
Beachwood OH 44122-5900
For Additional Information Contact Lynn A. Keller
216-831-0600
Manufacturer Reason
for Recall		 The wiring may allow the lamps to turn on with the key switch rather than the timer.
FDA Determined
Cause 2		 Employee error
Action Individual patients were contacted via telephone. Replacement devices have been distributed. The distributor was contacted via email. The firm has requested that consignees return the recalled device to their firm to be held under quarantine.
Quantity in Commerce 7 units
Distribution Worldwide distribution. US states: IA, IL, MI, NY, PA, and WI. Country: Jordan. There are no government accounts for this recall. There are no Canada accounts for this recall. There are no Mexico accounts for this recall.
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.
510(K) Database 510(K)s with Product Code = FTC and Original Applicant = NATIONAL BIOLOGICAL CORP.
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