Medical device recalls Moderate risk

International Science & Technology, LP, DBA Diamatrix Ltd. recalls Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, An…

Recall date
February 24, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1120-2022
FDA classification
Class II
Brand / firm
International Science & Technology, LP, DBA Diamatrix Ltd.
Sold / distributed
Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.

Why it was recalled

Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when the actual size is "2.2mm".

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

What was recalled

Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, Angled 6 units, Individual Packaging Label: ProTekt Sharps Safety Knives - REF: PG 44620MU,2.2mm double Bevel Slit, Sterile R, Angled 1 unit, Handle Labeling; 2.5mm slit double bevel

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