Z-0500-2018 Class II Terminated
FDA device recall Z-0500-2018 was initiated by Beaver-Visitec International Inc. on November 3, 2017 and is designated Class II. Reason for recall: The protective shield was retracted, and the blade was exposed. The recall status is terminated (terminated May 31, 2023). Affected quantity: 45, 680 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- November 3, 2017
- Termination Date
- May 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45, 680 units
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The protective shield was retracted, and the blade was exposed.
Distribution Pattern
Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
Code Information
(a) REF 370531; Batch numbers: 3185248 3191981 3193837 3199247 3201734 3204737 3206382 3208096 3211720 3213361 3214546 3217371 3219431 3222626 3225976 (b) REF 378233; Batch numbers: 3191985 3204382 3225442