International Science & Technology, LP, DBA Diamatrix Ltd. Recall 89827
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
International Science & Technology, LP, DBA Diamatrix Ltd. Recall 89827 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1120-2022 |
| Event ID | 89827 |
| Event 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 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany. |
| Quantity | 90 units |
| Recall 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". |
| Device Classification | 20220601 |
| Device Code Info | Item # PG 44620MU; Lot # : B923LUC |
| Center Classification Date | 20220520 |
| Recall Initiation Date | 20220224 |
| Recalling Firm | International Science & Technology, LP, DBA Diamatrix Ltd. |
| Initial Notification | Letter |
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