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U.S. Department of Health and Human Services

Class 2 Device Recall Respire Pink Hard/Soft

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  Class 2 Device Recall Respire Pink Hard/Soft see related information
Date Initiated by Firm September 01, 2017
Date Posted May 29, 2018
Recall Status1 Terminated 3 on December 09, 2019
Recall Number Z-1948-2018
Recall Event ID 80030
510(K)Number K150572  
Product Classification Dental Device, anti-snoring - Product Code LRK
Product Respire Pink+ Hard/Soft Oral Sleep Apnea Device
Code Information Serial Numbers: 51366, 51439, 51368, 51577, 51303, 52409, 51985, 51796, 51709, 51744, 51560, 51321, 51545, 51437, 51571, 51576, 51438, 51566, 51509, 51629, 51502, 51409, 51307, 51218, 51154, 51001, 51220, 51153 & 50807
Recalling Firm/
Manufacturer		 Respire Medical
18 Bridge St Ste 4J
Brooklyn NY 11201-1107
For Additional Information Contact
718-643-7326
Manufacturer Reason
for Recall		 Potential for device breakage during use
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 29 units
Distribution US nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LRK and Original Applicant = Respire Medical Holding
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