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U.S. Department of Health and Human Services

Class 2 Device Recall Beaver Visitec

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  Class 2 Device Recall Beaver Visitec see related information
Date Initiated by Firm February 02, 2024
Date Posted March 14, 2024
Recall Status1 Open3, Classified
Recall Number Z-1294-2024
Recall Event ID 93951
Product Classification Cannula, ophthalmic - Product Code HMX
Product BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye
Catalog Number: 581012
Code Information UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
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		 Pack and pouch label is missing the manufacturing and expiration date.
FDA Determined
Cause 2		 Under Investigation by firm
Action Beaver Visitec International issued URGENT FIELD SAFETY NOTICE- FA-24-001 letter on 1/19/24. 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 this FSN. 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 Field Safety Notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product. Please return any affected product to Sedgwick. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s). If you have any questions regarding this Field Action, please contact BVI Sedgwick at BVI8735@sedgwick.com or 8445934007. 4. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please include in the subject line: Master Case PIR 00538463 Please direct any questions regarding credit to our customer service department by email: ClaimsUS@bvimedical.com:
Quantity in Commerce 3,000 units (US and OUS)
Distribution Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
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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