—#163908

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.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K911160
Affected lot / code info: Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20 UDI: 30886158014899

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Beaver-Visitec International Inc.
Address: 411 Waverley Oaks Rd, Ste 229, Waltham, Massachusetts 02452-8422

Distribution

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

Timeline

Recall initiated: 2018-02-26
Terminated: 2019-01-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #163908. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.