FDA recall Z-1120-2022

International Science & Technology, LP, DBA Diamatrix Ltd. · Class II · device

Product

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".

Distribution

Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.

Key facts

Status
Completed
Initiation date
2022-02-24
Report date
2022-06-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Spring, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2022