Recall Z-1120-2022— International Science & Technology, LP, DBA Diamatrix Ltd.
Class II · Completed
Class II FDA medical device recall by International Science & Technology, LP, DBA Diamatrix Ltd., initiated 2022-02-24. FDA's recall record names no specific 510(k) clearance for this event. 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: 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"..
- Recalling firm
- International Science & Technology, LP, DBA Diamatrix Ltd.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2022-02-24
- Firm location
- Spring, TX, United States
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".
Data sourced from openFDA. This site is unofficial and independent of the FDA.