Recall Z-1802-2015— Beaver-Visitec International Inc.

Name: FDA recall Z-1802-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-01

Class II · Terminated

Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2015-05-01, terminated 2021-01-28. FDA's recall record names no specific 510(k) clearance for this event. Product: BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits. Reason: Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product.

Recalling firm: Beaver-Visitec International Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-05-01
Terminated: 2021-01-28
Firm location: Waltham, MA, United States

Product description

BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584569 Ophthalmic surgical kits

Reason for recall

Devon Light Glove in procedure kits may have holes/slits compromising sterility of the product

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