Protekt Sharps Safety Knives with Incorrect Size Label
International Science & Technology is recalling Protekt Sharps Safety Knives (PG 44620MU) because some handles are labeled with an incorrect blade size of 2.5mm when the actual size is 2.2mm.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm medical device where labeling inaccuracy could affect surgical outcomes if the wrong blade size is selected during procedures. No illnesses or injuries have been reported. The potential for patient harm from size selection errors warrants a High severity rating.
Plain-English summary
International Science & Technology, LP, DBA Diamatrix Ltd. is recalling Protekt Sharps Safety Knives (Reference PG 44620MU, Lot B923LUC). The surgical knives contain incorrect size descriptions printed on the handles: some handles are labeled "2.5mm" when the actual blade size is "2.2mm double bevel slit."
The size discrepancy on the handle labeling could lead to confusion during surgical procedures if healthcare providers select the wrong blade size for the intended application. This labeling error affects 90 units distributed in the United States (Minnesota and Texas) and Germany.
Healthcare facilities and users should verify the actual blade size of affected knives matches their surgical requirements. Contact the manufacturer with questions about affected units or for guidance on replacement.
The recalled product
- 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…
- Affected units
- 90
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item # PG 44620MU
- Lot # : B923LUC
Distribution
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