Home › LIFESTYLE CO INC, THE › PuriLens Plus Disinfecting System Exchange Kit
PuriLens Plus Disinfecting System Exchange Kit
LIFESTYLE CO INC, THE · Model MS0610/H · UDI-DI 00830002000056
10
510(k) clearances
324
Adverse events
14
Recalls
3
Facilities
Description
Exchange Kit contents: PuriLens Unit and removable cleaning/disinfecting chamber.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-10-04 | Family Dollar Stores, Llc. | Products were stored outside of labeled temperature requirements. |
| 2014-09-25 | Bausch & Lomb Inc- Greenville Solutions Plant | Product lot did not meet the specification for its disinfectants at the time of manufacture. |
| 2014-04-21 | Bausch & Lomb Inc- Greenville Solutions Plant | Out of specification results for one of the two disinfectants. |
| 2011-06-30 | Bausch & Lomb Inc | Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date. |
| 2010-12-22 | Bausch & Lomb Inc | There is a potential for some packages to not meet sterility requirements. |
| 2010-12-22 | Bausch & Lomb Inc | There is a potential for some packages to not meet sterility requirements. |
| 2010-02-03 | K C Pharmaceuticals Inc | The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination an |
| 2010-02-03 | K C Pharmaceuticals Inc | The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination an |
| 2010-02-03 | K C Pharmaceuticals Inc | The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination an |
| 2010-02-03 | K C Pharmaceuticals Inc | The recall was initiated because the affected lots were manufactured between two failed media fills; therefore the lots produced cannot be assured as being free of contamination an |
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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.