Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part

FDA device recall Z-0782-2023 · posted 2023-01-04 · Open, Classified

Recall details

Recalling firm

Beaver Visitec International, Inc.

Reason for recall

Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection

Action taken

Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. If you have further distributed this product, please notify your customers by initiating a sub-recall. Consider all potential users of this product in your user supply chain. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to Beavervisitec6269@sedgwick.com. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or Beavervisitec6269@sedgwick.com. If you have affected product, please return product with copy of BRF to: Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Attn: Event 6269 Stericycle 2670 Executive Drive, Suite A, Indianapolis, IN 46241 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR: 387823.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HNN

Quantity affected

599 units (US): 410 units; 189 kits

Distribution

US Nationwide distribution.

Date initiated

2022-11-30

Date posted

2023-01-04

Location

Waltham, MA