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
Recall
- Recall Number
- Z-1120-2022
- Event Number
- 89827
- Firm
- International Science & Technology, LP, DBA Diamatrix Ltd.
- FEI Number
- 3000892087
- Product Code
- HNN
- Status
- Completed
- Root Cause
- Labeling Change Control
- Initiated
- February 24, 2022
- Address
- 210 Nursery Rd, Spring, TX, 77380-1943
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
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".
Between the dates of February 16, 2022 - March 10, 2022, Diamatrix Ltd. issued a "Urgent: Medical Device Recall Notification. In addition to notifying consignees about the recalled product, the firm asked consignees to take the following actions: " Discontinue or do not use Diamatrix Item # PG 44620MU ProTekt 2.2mm Double Bevel Slit knives from Lot B923LUC. " Return the product to Diamatrix immediately. Please contact our customer service, 800-867-8081, to obtain a shipping label from Diamatrix. " Acknowledge this Voluntary Recall by returning the included Medical Device Recall Return Response letter within 3 business days of receiving this Recall letter. " A complimentary phone call to the phone numbers mentioned below would assist us with immediate tracking and reports to the FDA.
Worldwide distribution - US Nationwide distribution in the states of MN, TX and the country of Germany.
90 units