Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1081-2015 — 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 th

U.S. FDA — Device Enforcement · United States · 2014-11-26 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1081-2015
Date of alert: 2014-11-26
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Lacrimedics Inc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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