Respire Pink+ Hard Oral Sleep Apnea Device
FDA device recall Z-1949-2018 · posted 2018-05-29 · Terminated
Recall details
- Recalling firm
- Respire Medical
- Reason for recall
- Potential for device breakage during use
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LRK
- Quantity affected
- 25 units
- Distribution
- US nationwide distribution.
- Date initiated
- 2017-09-01
- Date posted
- 2018-05-29
- Date terminated
- 2019-12-09
- Location
- NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Respire Pink Series-Herbst-EF (K150572) | Respire Medical Holding | 2015-08-27 |