Home / Recalls / Beaver Visitec / Z-1111-2019

Z-1111-2019 Class II Terminated

Recalled by Beaver Visitec — Waltham, MA

Recall Details

Product Type
Devices
Report Date
April 17, 2019
Initiation Date
March 12, 2019
Termination Date
August 11, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
196 boxes (10units/box)

Product Description

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

Reason for Recall

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Distribution Pattern

Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS

Code Information

Lot Number: 6008554

Other recalls by Beaver Visitec

  • Z-1088-2019 Class III — Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30 (February 19, 2019)
  • Z-1066-2019 Class II — BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft T (November 30, 2018)
  • Z-3045-2018 Class II — Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Num (July 19, 2018)
  • Z-2740-2018 Class II — Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic s (June 18, 2018)
  • Z-2342-2018 Class II — Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make (May 14, 2018)