FDA-Device2022-06-01Class II
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
International Science & Technology, LP, DBA Diamatrix Ltd.
Hazard
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".
Sold states
Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.
Affected count
90 units
Manufactured in
210 Nursery Rd, Spring, TX, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2022Don't want to check this manually?
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