Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile R, Multi-Use 2.2mm Double Bevel Slit, A
Summary
The FDA issued a Class II for Outer Packaging Label: Protekt Sharps Safety Knives - REF: PG 44620MU, Sterile by International Science & Technology, LP, DBA Diamatrix Ltd.. Reason: Surgical knives may contain incorrect description printed on handles. Specifically, some surgical knife handles may contain a size of "2.5mm" when th.
Details
Source
Device Recall
External ID
Z-1120-2022
Action Date
2022-06-01
Status
Completed
Category
device
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
Lot/Code Info: Item # PG 44620MU; Lot # : B923LUC
Quantity Affected: 90 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-24
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (International Science & Technology, LP, DBA Diamatrix Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does International Science & Technology, LP, DBA Diamatrix Ltd. have FDA actions?
This is the only FDA action we have on record for International Science & Technology, LP, DBA Diamatrix Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1120-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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