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.
This recall has been terminated (originally issued February 26, 2018).
- Recall Initiated
- February 26, 2018
- Terminated
- January 28, 2019
- Recall Number
- Z-1539-2018
- Quantity
- 110 total products
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
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.