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U.S. Department of Health and Human Services

Class 2 Device Recall Xstar Kojo Safety Slit Knife

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  Class 2 Device Recall Xstar Kojo Safety Slit Knife see related information
Date Initiated by Firm October 10, 2023
Date Posted January 04, 2024
Recall Status1 Open3, Classified
Recall Number Z-0633-2024
Recall Event ID 93555
Product Classification Knife, ophthalmic - Product Code HNN
Product Xstar Kojo Safety Slit Knife, 2.5mm 45¿ Bevel Up, Part Number 373025
Code Information UDI-DI: 30886158000373; Lot Number: 6049877
Recalling Firm/
Manufacturer		 Beaver Visitec International, Inc.
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact Aminah Crawford
781-530-6377
Manufacturer Reason
for Recall		 One lot of Part Number 373025, Xstar¿ Kojo Safety Slit Knife 2.5mm 45¿ bevel up, incorrectly contains a bevel down blade instead of a bevel up blade.
FDA Determined
Cause 2		 Under Investigation by firm
Action An "URGENT Field Safety Notice" dated 10/10/23 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 Recall@bvimedical.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 00487979. 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
Quantity in Commerce 2160 units
Distribution International Distribution to Japan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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