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.
FDA Recall Z-1539-2018 · Posted None
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Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2018-02-26
Date Terminated2019-01-28
Product Quantity110 total products
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Distributed to the states of OH, NY, FL, MN, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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