PlainRecalls
FDA Devices Moderate Class II Ongoing

Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630

Reported: January 11, 2023 Initiated: November 30, 2022 #Z-0782-2023

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

Details

Units Affected
599 units (US): 410 units; 189 kits
Distribution
US Nationwide distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630. Recalled by Beaver Visitec International, Inc.. Units affected: 599 units (US): 410 units; 189 kits.
Why was this product recalled?
Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection
Which agency issued this recall?
This recall was issued by the FDA Devices on January 11, 2023. Severity: Moderate. Recall number: Z-0782-2023.