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

FDA device recall Z-0632-2024 · posted 2024-01-04 · Open, Classified

Recall details

Recalling firm

Beaver Visitec International, Inc.

Reason for recall

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

Action taken

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

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HNN

Quantity affected

1980 units

Distribution

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

Date initiated

2023-08-25

Date posted

2024-01-04

Location

Waltham, MA