Reported Feb 18, 2015 · Terminated
VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814,…
Lacrimedics Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Lacrimedics Inc · 2620 Williamson Place NW · DuPont, WA · 98327
Is this the product you have?
- VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as CollaSyn Plugs. Model number 1813, 1814, 1815, 1903, 1904, and 1905. This device is cylindrical in shape, approximately 1.75-2.00mm in length
- and available in three sizes0.3mm, 0.4mm and 0.5mm. Plugs are place in the upper and/or lower horizontal canaliculus. Two plugs are placed into a foam carrier and nitrogen sealed inside a foil pouch. The foil pouch is sent to sterilizer for gamma sterilization. Two sterile pouches are packaged in a box with an IFU
- Lot codes and dates
- LOT numbers
072314-2328072314-2329072314-2330081314-2365081314-2366081314-2367091814-2345091814-2350100614-2344
- EXPIRATION DATES
2018-05-152018-07-232018-08-132018-08-142018-09-142018-09-142018-09-252018-10-06
- LOT numbers
- Amount recalled
- 781 units
Where it was sold
Why it was recalled
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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