RecallDepth

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.

Company
Beaver-Visitec International Inc.
Recall Initiated
February 26, 2018
Terminated
January 28, 2019
Recall Number
Z-1539-2018
Quantity
110 total products
Firm Location
Waltham, MA

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.

Lot / Code Info

Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20  UDI: 30886158014899

Root Cause

Process control

Action Taken

On February 26, 2018, Beaver Visitec International Inc. emailed Product Recall Notices to affected customers. The letter identified the affected device and the reason for the recall. Customers were instructed to destroy affected product, provide evidence of the destruction, and complete a customer response form. Customers will receive a credit. Customers with questions regarding the recall may contact Customer Service at (866)906-8080.

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