FDAClass IIApril 17, 2019

Beaver Xstar Slit Knife 2.4 mm recall: Labeling Error

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic…

Why was Beaver Xstar Slit Knife 2.4 mm recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 6008554

Product
Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic…
Recalling firm
Beaver Visitec
Quantity
196 boxes (10units/box)
Distribution
Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Recall date
April 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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