Recall Z-1281-2022— Beaver Visitec International, Inc.

Name: FDA recall Z-1281-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-26

Class II · Ongoing

Class II FDA medical device recall by Beaver Visitec International, Inc., initiated 2022-04-26. It names one FDA 510(k) clearance: K911160. Product: BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251. Reason: Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250.

Recalling firm: Beaver Visitec International, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-04-26
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K911160 — MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305Mentor O & O, Inc.·cleared 1991-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

BVI Wet -Field Eraser, 18GA Blunt Tip, 45Deg.-Intended to remove tissue and control bleeding by the use of high frequency electrical current Part Number: 221251

Reason for recall

Boxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight, Part Number: 221250

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