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SOFT PLUG® Extended Duration Plugs
OASIS MEDICAL, INC. · Model 6400V · UDI-DI 00845819000267
LZU
Prescription
10
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities
Description
SOFT PLUG® Extended Duration Plug Variety Pack 20 Plugs Assorted: 2 eaches of 0.2mm DIA x 2mm Long (GTIN: 00845819000212) 6 eaches of 0.3mm DIA x 2mm Long (GTIN: 00845819000236) 8 eaches of 0.4mm DIA x 2mm Long (GTIN: 00845819000243) 4 eaches of 0.5mm DIA x 2mm Long (GTIN: 00845819000250)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-01-17 | Lacrimedics Inc | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| 2022-01-17 | Lacrimedics Inc | The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility. |
| 2014-11-26 | Lacrimedics Inc | Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained. |
| 2006-07-06 | Oasis Medical Inc | Labeled with an incorrect diameter |
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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.