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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = FTC
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