Recall Z-0782-2023— Beaver Visitec International, Inc.

Name: FDA recall Z-0782-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-30

Class II · Ongoing

Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2022-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Beaver EdgeAhead Stiletto/MVR Knife .90mm Straight (20G)-for ocular paracentesis incisions in cataract procedures. Part Number: 376630. Reason: Packaging sterile barrier has been compromised. Open seals can lead to a loss of device sterility and may lead to infection.

Recalling firm: Beaver Visitec International, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-30
Firm location: Waltham, MA, United States

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.