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
Z-1120-2022
Product summary
- Event
- Event 89827
- Status
- Completed
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-1120-2022
Official wording
Reason: 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".
Code information: Item # PG 44620MU; Lot # : B923LUC
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.
Derived failure modes
-
Unknown
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".