Recalls / —

—#189681

Product

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

FDA product code

HNN — Knife, Ophthalmic

Device class

Class 1

Medical specialty

Ophthalmic

Affected lot / code info

LOT#: 6000842, 6002045, 6011609, 6034238, 6040517, 6042907. UDI: " Primary: 00886158000594 " Secondary: 30886158000595 " Tertiary: 50886158000599

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 beavervisitec3997@sedgwick.com 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 ClaimsUS@bvimedical.com and please include in the subject line: Master Case PIR 263383

Recalling firm

Firm

Beaver Visitec International, Inc.

Address

500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern

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

Timeline

Recall initiated

2021-10-08

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #189681. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.