Home / Recalls / Beaver Visitec / Z-1066-2019

Z-1066-2019 Class II Terminated

Recalled by Beaver Visitec — Waltham, MA

Recall Details

Product Type
Devices
Report Date
April 3, 2019
Initiation Date
November 30, 2018
Termination Date
May 1, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3430 units

Product Description

BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where appropriate (e.g. retinal, subretinal procedures).

Reason for Recall

Certain lots are missing a protective sheath component over the silicone tip, which may result in the silicone tip breaking or detaching at the metal tube component. If the tip becomes detached during a procedure while in the eye, the fragment will need to be retrieved to mitigate the possibility of injury.

Distribution Pattern

Worldwide distribution: US (nationwide) to states of: AR, AZ, CA, CO, FL, GA, LA, MD, MO, NC, NE, NJ, NY, OH, OK, TX, UT, VA, WA; and countries of: Mexico and Peru.

Code Information

Lots 60047S4, 60060S9, 600623S

Other recalls by Beaver Visitec

  • Z-1111-2019 Class II — Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in C (March 12, 2019)
  • Z-1088-2019 Class III — Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30 (February 19, 2019)
  • 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)