ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
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 recall involving medical devices with potential for sterile barrier compromise. No illnesses or injuries have been reported, and the hazard is theoretical (packaging "may result" in breach), so the severity is limited to High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE sterile medical procedure kits due to packaging issues that may result in a breach of the sterile barrier. The two affected models are the ECONO STERILE FREER ELEV DE S/B 7.25" CS/25 (Model 96-2483, for multiple purposes) and ECONO STERILE LOCKE ELEV #94 NARROW STER 25 (Model 96-2484, for foot procedures). The recall affects 125 units distributed nationwide.
A breach in the sterile barrier could allow contamination of the medical device, potentially resulting in infections or other adverse events during surgical or medical procedures.
Healthcare providers and medical facilities that have received these kits should discontinue use and contact Sklar Instruments. The recalled lot codes are FSS5 for Model 96-2483 and SK-115 for Model 96-2484.
The recalled product
- Product
- ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- packaging-defect
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 (6)
- 1) 96-2483
- UDI/DI 50649111449053
- Lot codes: FSS5
- 2) 96-2484
- UDI/DI 50649111492950
- Lot codes: SK-115
Distribution
Distributed nationwide across the United States.
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