Medical device recalls Moderate risk

Hager & Meisinger Gmbh recalls Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/…

Recall date
November 7, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0493-2020
FDA classification
Class II
Brand / firm
Hager & Meisinger Gmbh
Sold / distributed
US: NV, PA, FL, SC, IA, NC-

Why it was recalled

Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade packaging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245; Reference: HMUN245-009; Shank: FG/314; Head Size 1/10mm: 009,Head Length/mm:

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