Recalls / —

—#198020

Product

CustomEyes kits

FDA product code

KDD — Kit, Surgical Instrument, Disposable

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Catalog #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

Why it was recalled

Device packaging may contain open seals, compromising product sterility.

Root cause (FDA determination)

Process control

Action the firm took

A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.

Recalling firm

Firm

Beaver Visitec International, Inc.

Address

500 Totten Pond Rd, 10, City Point Waltham, Massachusetts 02451-1916

Distribution

Distribution pattern

US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa

Timeline

Recall initiated

2022-12-20

Posted by FDA

2023-03-01

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #198020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.