Recalls / —

—#198019

Product

Ultracell Wick with 80cc Collection Bag, 20/box

FDA product code

HOZ — Sponge, Ophthalmic

Device class

Class 2

Medical specialty

Ophthalmic

510(k) numbers

K920354

Affected lot / code info

Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123

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 #198019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.