U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Dental Device, anti-snoring - Product Code LRK
원인
Potential for device breakage during use.
조치
On or about September 6, 2017, Respire & Whole You distributed untitled notices to their customers. Respire & Whole You notified customers that they received reports of device breakage. Respire & Whole You offered to send replacements to all impacted customers. On May 23, 2018, Respire & Whole You issued URGENT MEDICAL DEVICE RECALL notices and response forms to their customers. Customers were advised to take the following actions:
- Immediately examine your inventory, discontinue use and quarantine product subject to recall.
- In addition, if you may have further distributed this product, please identify your customers and notify them of the product recall by providing them with a copy of the notice.
- Once Respire & Whole You receives your returned device, the firm will remake and ship you a completely new Pink+ appliance with the original Scheu arms at no charge.
Customers with questions may call (718) 643-7326, Monday Friday 7am to 7pm.