FDA recall Z-1539-2018

Product

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.

Distribution

Distributed to the states of OH, NY, FL, MN, and KS.

Key facts

Status

Terminated

Initiation date

2018-02-26

Report date

2018-05-09

Termination date

2019-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1539-2018