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Terminated

Respire Pink H/S Oral Sleep Apnea Device

FDA Recall Z-1951-2018 · Posted 2018-05-29

Recalling FirmRespire Medical
Recall StatusTerminated
Product CodeLRK
Date Initiated2017-09-01
Date Terminated2019-12-09

Reason for Recall

Potential for device breakage during use

Firm Action

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

Distribution Pattern

US nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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