Home / Recalls / Beaver-Visitec International Inc. / Z-1539-2018

Z-1539-2018 Class II Terminated

Recalled by Beaver-Visitec International Inc. — Waltham, MA

Recall Details

Product Type
Devices
Report Date
May 9, 2018
Initiation Date
February 26, 2018
Termination Date
January 28, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
110 total products

Product Description

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.

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 Pattern

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

Code Information

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

Other recalls by Beaver-Visitec International Inc.

  • Z-1008-2026 Class II — BVI Leos Laser and Endoscopy System. Model Number: OME6000U. (December 5, 2025)
  • Z-1801-2018 Class II — Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 2 (February 26, 2018)
  • Z-0504-2018 Class II — bvi Beaver Optimum Safety Sideport Knife: (a) Straight 15o, REF 378235 (b) S (November 3, 2017)
  • Z-0501-2018 Class II — bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, R (November 3, 2017)
  • Z-0502-2018 Class II — bvi Beaver Xstar Safety Slit Knife: (a) REF 378214, 1.4mm, 45o Bevel Up (b) (November 3, 2017)
  • Z-0503-2018 Class II — bvi Beaver Xstar Safety Crescent, 2.5mm, 55o Bevel Up, REF 378234 Product U (November 3, 2017)
  • Z-0500-2018 Class II — bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) (November 3, 2017)
  • Z-1803-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)
  • Z-1804-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)
  • Z-1805-2015 Class II — BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove (May 1, 2015)