Beaver Visitec International, Inc. BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Brand
Beaver Visitec International, Inc.
Lot Codes / Batch Numbers
UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
Products Sold
UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926
Beaver Visitec International, Inc. is recalling BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye C due to Pack and pouch label is missing the manufacturing and expiration date.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Pack and pouch label is missing the manufacturing and expiration date.
Recommended Action
Per FDA guidance
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:
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026