Recall Z-1111-2019— Beaver Visitec
Class II · Terminated
Class II FDA medical device recall by Beaver Visitec, initiated 2019-03-12, terminated 2020-08-11. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: 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.
- Recalling firm
- Beaver Visitec
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-12
- Terminated
- 2020-08-11
- Firm location
- Waltham, MA, United States
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.