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U.S. Department of Health and Human Services

Class 2 Device Recall Pelleve

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 Class 2 Recall
Pelleve
see related information
Date Posted May 17, 2012
Recall Status1 Open
Recall Number Z-1624-2012
Recall Event ID 61801
Premarket Notification
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, New York 11572-3625
Manufacturer Reason
for Recall
Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = ELLMAN INT'L INC.
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