—#205993

Product

BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012

FDA product code: HMX — Cannula, Ophthalmic
Device class: Class 1
Medical specialty: Ophthalmic
Affected lot / code info: UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926

Why it was recalled

Pack and pouch label is missing the manufacturing and expiration date.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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:

Recalling firm

Firm: Beaver Visitec International, Inc.
Address: 500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.

Timeline

Recall initiated: 2024-02-02
Posted by FDA: 2024-03-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205993. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.