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U.S. Department of Health and Human Services

Class 2 Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED

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  Class 2 Device Recall WETFIELD OSHER THERMODOT MARKER, 25GA FINE TIP, CURVED see related information
Date Initiated by Firm February 26, 2018
Create Date April 27, 2018
Recall Status1 Terminated 3 on January 28, 2019
Recall Number Z-1539-2018
Recall Event ID 79908
510(K)Number K911160  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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.
Code Information Lot numbers: 6000292 exp. 7/25/20 and 6000540 exp. 08/30/20  UDI: 30886158014899
Recalling Firm/
Manufacturer		 Beaver-Visitec International Inc.
411 Waverley Oaks Rd Ste 229
Waltham MA 02452-8422
For Additional Information Contact Max Cox
781-906-8080
Manufacturer 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.
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 110 total products
Distribution Distributed to the states of OH, NY, FL, MN, and KS.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = MENTOR O & O, INC.
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