Z-1294-2024Class II

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

Name: Z-1294-2024 BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog...
Creator: Beaver Visitec International, Inc.
Published: 2024-02-02
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2024-02-02 / Open, Classified / root cause: labeling and UDI

FDA source

Beaver Visitec International, Inc. began a recall of BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012 on 2024-02-02. FDA classified it as Class II and gives the reason as "Pack and pouch label is missing the manufacturing and expiration date". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1294-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-02
Posted: 2024-03-14
Recalling firm: Becton Dickinson & Co
Product: BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012
Product code: HMX Cannula, Ophthalmic
Reason for recall: Pack and pouch label is missing the manufacturing and expiration date.
Root cause tag: labeling and UDI
FDA root cause: 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 [email protected] 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: [email protected]:
Quantity in commerce: 3,000 units (US and OUS)
Distribution: Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, GERMANY, SWITZERLAND, UNITED KINGDOM.
Product codes and lots: UDI Number: 50886158002227 Lot Number: 21C0925 & 21C0926

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1294-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1294-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code HMX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)