Z-1111-2019Class II

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma...

Name: Z-1111-2019 Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma...
Creator: Beaver Visitec
Published: 2019-03-12
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-03-12 / Terminated / root cause: packaging

FDA source

Beaver Visitec began a recall of Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic... on 2019-03-12. FDA classified it as Class II and gives the reason as "Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1111-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-12
Posted: 2019-04-09
Terminated: 2020-08-11
Recalling firm: Becton Dickinson & Co
Product: Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures
Product code: HNN Knife, Ophthalmic
Reason for recall: Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Beaver-Visitec International, Inc.(BVI) initiated recall by letter on 3/12/19 advising users of the problem, action to take: immediately examine inventory and quarantine product from this lot subject to mplete and return the enclosed Product Recall Notice Response & Return Form recall, Return ALL quarantined product from the affected lot. Questions you may contact our Customer Service Team at:[email protected] or call 866-906-8080 from 8 A.M. to 6 P.M. EST (Monday-Friday).
Quantity in commerce: 196 boxes (10units/box)
Distribution: Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Product codes and lots: Lot Number: 6008554

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1111-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1111-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-17	2019-04-09

Product code HNN

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)