PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 9, 2018 Initiated: February 26, 2018 #Z-1539-2018

Product Description

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.

Reason for Recall

Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.

Details

Units Affected
110 total products
Distribution
Distributed to the states of OH, NY, FL, MN, and KS.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Beaver-Visitec International Inc.. Units affected: 110 total products.
Why was this product recalled?
Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 9, 2018. Severity: Moderate. Recall number: Z-1539-2018.