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SOFT PLUG® Collagen Canalicular Plugs
OASIS MEDICAL, INC. · Model 6200V · UDI-DI 00845819005385
LZU
Prescription
10
510(k) clearances
163
Adverse events
4
Recalls
37
Facilities
Description
SOFT PLUG® Extended Duration 180 Collagen Plug, Variety Pack: Assorted Plugs: 6 eaches of 0.3mm 180 Canalicular Plug (GTIN: 00845819004029) 8 eaches of 0.4mm 180 Canalicular Plug (GTIN: 00845819005361) 6 eaches of 0.5mm 180 Canalicular Plug (GTIN: 00845819005378)
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.