Date Initiated by Firm |
May 04, 2012 |
Date Posted |
May 17, 2012 |
Recall Status1 |
Terminated 3 on February 12, 2016 |
Recall Number |
Z-1624-2012 |
Recall Event ID |
61801 |
510(K)Number |
K082834
|
Product Classification |
Electrosurgical, cutting; coagulation; accessories - Product Code GEI
|
Product |
Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance through science --- Contents: One (1) Pelleve Handpiece (Reusable) --- Non-ablative treatment of mild to moderate facial wrinkles and rhytids for skin phototypes I-IV. |
Code Information |
All lots of the Pelleve handpieces (product codes D110FSHP, D115FSHP only) manufactured to date are subject to this recall. |
Recalling Firm/ Manufacturer |
Ellman International, Inc. 3333 Royal Ave Oceanside NY 11572-3625
|
For Additional Information Contact |
877-552-7141
|
Manufacturer Reason for Recall |
Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
|
FDA Determined Cause 2 |
Equipment maintenance |
Action |
Ellman will notify all consignees initially via UPS shipment with an Urgent: Medical Device Recall letter containing notification of the recall and instructions. The letter identifies the affected product, problem, and instructs customers to identify and return the handpieces in the enclosed prepaid mailer. Customers are to complete and return the Product Recall Verification Form and fax it to the number provided. In addition, customers are provided with a toll-free number, 1-877-522-7141, to call in the event that they have questions or require additional instruction. Customers will initially be provided with a fixed-life disposable GlideSafe handpiece and may choose to receive a replacement reusable handpiece with modified (more robust) cable, or additional GlideSafe handpieces. |
Quantity in Commerce |
1,088 units |
Distribution |
Worldwide Distribution |
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.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = ELLMAN INT'L INC.
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