ECONO STERILE Blackhead Extractor Kits Recalled for Sterile Packaging Defects
Sklar Instruments is recalling ECONO STERILE Schamberg Extractor kits due to packaging issues that may compromise the sterile barrier. The defect could allow contamination of medical instruments.
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: This is an FDA Class II recall of medical procedure kits where packaging defects may compromise sterile barriers. The hazard is risk-of-harm (potential infections from contaminated instruments) with no reported illnesses or injuries to date, meeting the High severity criterion for risk-of-harm products without confirmed harm.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE Schamberg Extractor kits, Model 96-2395M, due to various packaging issues that may result in a breach of the sterile barrier. These medical procedure kits were distributed nationwide.
The packaging defect creates a potential risk to patient safety. If the sterile barrier is compromised, the medical instruments may become contaminated during storage or handling prior to use, which could introduce infection risk for patients who receive procedures using these extractors.
No illnesses or injuries related to this defect have been reported. Healthcare facilities and individuals in possession of the affected kits should contact Sklar Instruments for information about this recall.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
- Manufacturer
- Sklar Instruments
- Hazard
- packaging-defect
- sterile-barrier-breach
- infection-risk
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 (3)
- 96-2395M
- UDI/DI 50649111448896
- Lot codes: SK-133
Distribution
Distributed nationwide across the United States.
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