Recalls / —

—#204703

Product

Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807

FDA product code

HNN — Knife, Ophthalmic

Device class

Class 1

Medical specialty

Ophthalmic

Affected lot / code info

UDI-DI: 30886158000571; Lot Number: 6054027

Why it was recalled

One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

An URGENT Field Safety Notice dated 8/25/23 was sent to customers. Actions Required by You Our records show you received one or more affected product. You can recognize the affected product by determining whether the lot number printed on the device label is one of the affected lots. PLEASE perform the following actions: 1. Immediately examine your inventory and determine if the blades on the knives are bevel-up as intended or bevel down. Only destroy the knives in your inventory that have the incorrect bevel orientation (bevel down). 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. You are encouraged to use a copy of this recall notification letter when contacting your customers. 2. Review the enclosed Business Reply Form (BRF) and indicate whether you have the affected product in your possession. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) destroyed. 4. Return the completed BRF and evidence of destruction of affected product to BVI by emailing the attached to BVICrescentKnife@Sedgwick.com BVI values your business and apologizes for the inconvenience this may have caused. Please direct any questions regarding credit to our customer service department by email and include in the subject line: Master Case PIR 00474923. Country Customer Service Email UK UKCustomerSupport@bvimedical.com FR serviceclient@bvimedical.com DE/ AT Kundendienst@bvimedical.com IT servizioclienti@bvimedical.com ROW ROWCustomerSupport@bvimedical.com

Recalling firm

Firm

Beaver Visitec International, Inc.

Address

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

Distribution

Distribution pattern

International distribution to the countries of Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, Sweden.

Timeline

Recall initiated

2023-08-25

Posted by FDA

2024-01-04

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #204703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.