Recall Z-1801-2018— Beaver-Visitec International Inc.

Name: FDA recall Z-1801-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-26

Class II · Terminated

Class II FDA medical device recall by Beaver-Visitec International Inc., initiated 2018-02-26, terminated 2019-10-30. It names one FDA 510(k) clearance: K911160. Product: Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549. Reason: Products were packaged with incorrect labeling,.

Recalling firm: Beaver-Visitec International Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-02-26
Terminated: 2019-10-30
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

Wet-Field Hemostatic Eraser Bipolar 25G, fine tip, straight, 5/SP; Part Number 221267; UDI: 30886158010549

Reason for recall

Products were packaged with incorrect labeling,

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