Conventional Knife Crescent 2.5mm, 55 degrees bevel up, Part Number 373807
This recall is currently active, issued January 4, 2024. It was issued by Beaver Visitec International, Inc..
- Recall Initiated
- August 25, 2023
- Posted
- January 4, 2024
- Recall Number
- Z-0632-2024
- Quantity
- 1980 units
- Firm Location
- City Point Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
One lot of Conventional Crescent Knife 2.5mm, 55 degrees bevel-up contains a bevel down blade.
Distribution
International distribution to the countries of Belgium, China, France, Germany, Greece, Italy, Jordan, Lithuania, Netherlands, Oman, Poland, Spain, Sweden.
Lot / Code Info
UDI-DI: 30886158000571; Lot Number: 6054027
Root Cause
Under Investigation by firm
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