Recall Z-0500-2018— Beaver-Visitec International Inc.
Class II · Terminated
Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2017-11-03, terminated 2023-05-31. FDA's recall record names no specific 510(k) clearance for this event. Product: bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.. Reason: The protective shield was retracted, and the blade was exposed..
- Recalling firm
- Beaver-Visitec International Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-11-03
- Terminated
- 2023-05-31
- Firm location
- Waltham, MA, United States
Product description
bvi Beaver EdgeAhead Safety Knife, (a) Sideport MVR .90mm 20G, REF 370531 (b) Sideport Angled, .60mm (23G), REF 378233 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
Reason for recall
The protective shield was retracted, and the blade was exposed.
Data sourced from openFDA. This site is unofficial and independent of the FDA.