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.
Recall
- Recall Number
- Z-1624-2012
- Event Number
- 61801
- Firm
- Ellman International, Inc.
- FEI Number
- 2428235
- Product Code
- GEI
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- May 4, 2012
- Posted
- May 17, 2012
- Terminated
- February 12, 2016
- Address
- 3333 Royal Ave, Oceanside, NY, 11572-3625
Description
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.
Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
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.
Worldwide Distribution
1,088 units