Z-1111-2019 Class II Terminated
FDA device recall Z-1111-2019 was initiated by Beaver Visitec on March 12, 2019 and is designated Class II. 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 The recall status is terminated (terminated August 11, 2020). Affected quantity: 196 boxes (10units/box).
Recall Details
- Product Type
- Devices
- Report Date
- April 17, 2019
- Initiation Date
- March 12, 2019
- Termination Date
- August 11, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 196 boxes (10units/box)
Product Description
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
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
Distribution Pattern
Worldwide Distribution - US Nationwide Foreign:UNITED KINGDOM JAPAN NETHERLANDS
Code Information
Lot Number: 6008554