Home / Recalls / Beaver Visitec / Z-2342-2018

Z-2342-2018 Class II Terminated

Recalled by Beaver Visitec — Waltham, MA

FDA device recall Z-2342-2018 was initiated by Beaver Visitec on May 14, 2018 and is designated Class II. Reason for recall: Blades are loose in handles and may fall out due to non cured epoxy The recall status is terminated (terminated June 8, 2021). Affected quantity: 1354 units.

Recall Details

Product Type: Devices
Report Date: July 11, 2018
Initiation Date: May 14, 2018
Termination Date: June 8, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1354 units

Product Description

Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make stab incisions during ophthalmic surgery

Reason for Recall

Blades are loose in handles and may fall out due to non cured epoxy

Distribution Pattern

US Nationwide in the states of CA, IA, CO, HI, IA, MD & TX

Code Information

Lot Numbers: 6002436 & 6002663

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-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)