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Restored Rest
Restored Rest LLC · Model Full Style S/M · UDI-DI 00860009595804
10
510(k) clearances
209
Adverse events (1 deaths)
6
Recalls
391
Facilities
Description
CPAP mask cushion cover made of absorbent material. Helps make using a CPAP easier and more comfortable. Decreases slippage, leaks, and noise. Feels good on the skin. Keeps the cushion clean and extends the life of the cushion. Slips on the cushion easily and is held on by thin elastic. Patented design is slim and lightweight. As the cover goes on the cushion a space for the nose, or nose and mouth, opens automatically. Washable and reusable.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-25 | Medline Industries Inc | Potential for mold contamination (Aspergillus vadensis) |
| 2017-12-11 | Medical Action Industries Inc | Product sterility potentially compromised. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2009-07-21 | Coloplast Corp Skin Care Div | Coloplast determined that a portion of one lot of InterDry" Ag Lot number 1789435, did not meet the product specification for silver content. In this portion of the lot antimicrob |
| 2006-02-09 | 3M Company / Medical Division | After reviewing manufacturing records it has been determined that these lots inadvertently were not sterilized after packaging in individual boxes labeled as sterile product. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.