ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.
What this means for you
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: FDA Class II medical device recall where packaging defects may compromise sterile barriers on surgical instruments. No illnesses or injuries have been reported, but the risk-of-harm potential of non-sterile equipment use during procedures justifies a High severity rating.
Plain-English summary
Sklar Instruments is recalling six models of ECONO STERILE medical procedure kits used for nail care procedures. The recalled products include nail nippers and tissue nippers in various sizes, identified by model numbers 96-2424A, 96-2427, 96-2666, 96-2666A, 96-2667, and 96-2671A. Approximately 7,730 units were affected and distributed nationwide.
The kits are being recalled due to packaging issues that may result in a breach of the sterile barrier. A breached sterile barrier would allow the medical instruments to become non-sterile, potentially compromising patient safety if the equipment is used for medical procedures.
The affected products can be identified by their model numbers and specific lot codes (SK-112, SK-118, and SK-131).
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STER
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination
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 (17)
- 1) 96-2424A
- UDI/DI 50649111484504
- Lot codes: SK-112
- 2) 96-2427
- UDI/DI 50649111449008
- Lot codes: SK-131
- 3) 96-2666
- UDI/DI 50649111078918
- Lot codes: SK-118
- 4) 96-2666A
- UDI/DI 50649111488120
- SK-118
- 5) 96-2667
- UDI/DI 50649111079090
- 6) 96-2671A
- UDI/DI 50649111488113
- Lot codes: SK-112.
Distribution
Distributed nationwide across the United States.
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