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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm October 08, 2021
Create Date November 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0228-2022
Recall Event ID 88826
Product Classification Eye tray - Product Code OJK
Product bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
Code Information Lot Numbers 3296729, 3299124, 3305081, 3307565, 3312464, 3324620, 6033588. UDI: " Primary: 00886158112839 " Secondary: 30886158112830 " Tertiary: 50886158112834
Recalling Firm/
Manufacturer
Beaver Visitec International, Inc.
500 Totten Pond Rd
10 City Point
Waltham MA 02451-1916
For Additional Information Contact SAME
781-906-7950
Manufacturer Reason
for Recall
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
FDA Determined
Cause 2
Under Investigation by firm
Action BVI notified Consignees by Urgent Medical Device Recall letter on 10/8/21 via registered mail. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from these lots that are subject to recall. If you have further distributed this product, please notify your customers by initiating a subrecall. Consider all potential users of this product in your user supply chain. You are encouraged to a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Reply Form (BRF) and indicate whether you have affected product to return. 3. Please enter the following information on the enclosed BRF: part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. Return the completed BRF to BVI by one of these methods: " Fax to 866-552-4919 " Email the attached to beavervisitec3997@sedgwick.com 5. Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Stericycle 2670 Executive Drive, Suite A Indianapolis, IN 46241 Attn: Event 3997 If you received this notification without the prepaid UPS label and Business Reply Form (BRF), and require additional shipping labels, or if you have questions regarding the return procedure, please contact Stericycle Inc. at 866-606-8264 (Mon.-Fri. 8:00 am - 5:00 pm Eastern Time). Please direct any questions regarding this matter to our customer service department by email ClaimsUS@bvimedical.com and please include in the subject line: Master Case PIR 263383
Quantity in Commerce 500 eaches
Distribution Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan Russia South Africa UK
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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