FDA Recall Open, Classified

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

Recall: Z-0632-2024 · Initiated August 25, 2023

Recall

Recall Number
Z-0632-2024
Event Number
93547
Firm
Beaver Visitec International, Inc.
FEI Number
1211998
Product Code
HNN
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
August 25, 2023
Posted
January 4, 2024
Address
500 Totten Pond Rd, 10, City Point Waltham, MA, 02451-1916

Description

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

Reason

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

Action

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 [email protected] 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 [email protected] FR [email protected] DE/ AT [email protected] IT [email protected] ROW [email protected]

Distribution

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

Quantity

1980 units