Z-1081-2015 Class III Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 18, 2015
- Initiation Date
- November 26, 2014
- Termination Date
- March 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 781 units
Product Description
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 sizes: 0.3mm, 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.
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution-US (nationwide) including the states of AR, CA, FL, ID, IL, KS, MA, MI, NC, NJ, NY, OR, PA, and TX and to the countries of Australia, Brazil, Czech Republic, France, Ireland, Mexico, Peru, Switzerland, and United Kingdom.
Code Information
LOT numbers: 072314-2328; 072314-2329; 072314-2330; 081314-2365; 081314-2366; 081314-2367; 091814-2345; 091814-2350; 100614-2344; EXPIRATION DATES: 2018-05-15; 2018-07-23; 2018-08-13; 2018-08-14; 2018-09-14; 2018-09-14; 2018-09-25; 2018-10-06;