FDA recall Z-0782-2023

Beaver Visitec International, Inc. · Class II · device

Product

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

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2022-11-30
Report date
2023-01-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waltham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0782-2023