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

Recall Z-1539-2018 — WET-FIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED; Part number 221270. Designed to create an ink-free, fine dot on the eye that can be used as a precise reference point for a variety of procedures.

U.S. FDA — Device Enforcement · United States · 2018-02-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1539-2018
Date of alert
2018-02-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beaver-Visitec International Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30886158014899
Reported risk: Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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