Pelleve Non-Ablative Wrinkle Treatment Handpiece, Product Codes D110FSHP, D115FSHP (reusable) --- Pelleve --- Elegance t
FDA device recall Z-1624-2012 · posted 2012-05-17 · Terminated
Recall details
- Recalling firm
- Ellman International, Inc.
- Reason for recall
- Ellman International is recalling its Pelleve reusable handpiece because of possible cable failure and sparking.
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 1,088 units
- Distribution
- Worldwide Distribution
- Date initiated
- 2012-05-04
- Date posted
- 2012-05-17
- Date terminated
- 2016-02-12
- Location
- Oceanside, NY
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELLMAN INTERNATIONAL NON-ABLATIVE TECHNIQUE FOR SURGITRON IEC (K082834) | Ellman Int'L, Inc. | 2009-05-07 |