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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 November 30, 2022
Date Posted January 04, 2023
Recall Status1 Open3, Classified
Recall Number Z-0782-2023
Recall Event ID 91235
Product Classification Knife, ophthalmic - Product Code HNN
Product Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures.
Part Number: 376630
Code Information UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035
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		 Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
FDA Determined
Cause 2		 Under Investigation by firm
Action Beaver Visitec (BVI) issued Urgent Medical Device Recall Letter (FA-22-006) on 11/30/22 via certified mail to Distributors/Customers. Letter states reason for recall, health risk and action to take: 1. Immediately examine your inventory and quarantine product from the lot that is subject to this recall. 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. Use a copy of this recall notification letter when contacting your customers. 2. Complete the enclosed Business Response Form (BRF) and indicate whether or not you have affected product to return. Please return the business reply form to Beavervisitec6269@sedgwick.com. 3. Please enter the following information on the enclosed BRF: company name, part number(s), lot number(s) and quantity(ies) of device(s) that are being returned. 4. If you have any questions regarding this Field Action, please contact BVI at 888-708-5723 or Beavervisitec6269@sedgwick.com. If you have affected product, please return product with copy of BRF to: Return your product to STERICYCLE using the enclosed UPS pre-paid return label: Attn: Event 6269 Stericycle 2670 Executive Drive, Suite A, Indianapolis, IN 46241 Credit will be provided to consignees who have replied with confirmation of receiving affected product. Please direct any questions regarding credit to our customer service department by email ClaimsUS@bvimedical.com and include in the subject line: Master Case PIR: 387823.
Quantity in Commerce 599 units (US): 410 units; 189 kits
Distribution US Nationwide distribution.
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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