Z-0782-2023 Class II Ongoing
FDA device recall Z-0782-2023 was initiated by Beaver Visitec International, Inc. on Nov 30, 2022 and is designated Class II. Reason for recall: Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection The recall status is ongoing. Affected quantity: 599 units (US): 410 units; 189 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 11, 2023
- Initiation Date
- Nov 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 599 units (US): 410 units; 189 kits
Product Description
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630
Reason for Recall
Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
Distribution Pattern
US Nationwide distribution.
Code Information
UDI: 00886158100010 Lot Number: 3391035 Additionally Packaged as a component of the READYPAK KIT Cat: 584896 Lots: 6054175, 6053035
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0782-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026