Recall Z-1539-2018— Beaver-Visitec International Inc.

Name: FDA recall Z-1539-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-26

Class II · Terminated

Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2018-02-26, terminated 2019-01-28. It names one FDA 510(k) clearance: K911160. 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: Incorrect tip was used during manufacturing of the Osher Thermodot Marker. The markers have a needle tip instead of the proper flat tip..

Recalling firm: Beaver-Visitec International Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Terminated: 2019-01-28
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305Mentor O & O, Inc.·cleared 1991-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.