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Terminated

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

FDA Recall Z-1801-2018 · Posted None

Recalling FirmBeaver-Visitec International Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2018-02-26
Date Terminated2019-10-30
Product Quantity1025

Reason for Recall

Products were packaged with incorrect labeling,

Firm Action

On 2/26/18 Beaver-Visitec emailed product recall notices to affected customers. Customers were instructed to destroy the affected product, provide objective evidence of the product destruction, then complete and return the customer response form. Customers with questions regarding this recall may contact Customer Service at (866)906-8080.

Root Cause

Labeling mix-ups

Distribution Pattern

US Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911160MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305Mentor O & O, Inc. · 1991-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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