FDA Recall Open, Classified

Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

Recall: Z-0227-2022 · Initiated October 8, 2021

Recall

Recall Number
Z-0227-2022
Event Number
88826
Firm
Beaver Visitec International, Inc.
FEI Number
1211998
Product Code
HNN
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
October 8, 2021
Address
500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

Description

Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809

Reason

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

Action

BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-552-4919 " Email the attached to [email protected] 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3997 If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time). Please direct any questions regarding this matter to our customer service department by email [email protected] and please include in the subject line: Master Case PIR 263383

Distribution

Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK

Quantity

5950 eaches