PlainRecalls
FDA Devices Moderate Class II Completed

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

Reported: June 1, 2022 Initiated: February 24, 2022 #Z-1120-2022

Product Description

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

Reason for Recall

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".

Details

Units Affected
90 units
Distribution
Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.
Location
Spring, TX

Frequently Asked Questions

What product 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. Recalled by International Science & Technology, LP, DBA Diamatrix Ltd.. Units affected: 90 units.
Why was this product 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".
Which agency issued this recall?
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1120-2022.