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SALTER LABS · Model 8150TLC-7 · UDI-DI 00607411891786
BYF
Prescription
10
510(k) clearances
27
Adverse events
3
Recalls
94
Facilities
Description
Percent-O2-Lock® Mask (Adult) with foam cushions with 7’ (2.1 m) supply tube.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-03-25 | Salter Laboratories, Division of Regulatory Affairs | A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy. |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
| 2011-02-11 | Smiths Medical | A sticky substance on the inside and/ or outside of the Mask |
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