ECONO STERILE medical procedure kits recalled for sterile barrier breach risk
Sklar Instruments recalls ECONO STERILE blackhead extractor kits (Model 96-2395M) due to packaging issues that may compromise the sterile barrier. Affected units nationwide should not be used.
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: Class II device recall for potential sterile barrier breach with no reported illnesses or injuries. This is a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE medical procedure kits labeled as ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25 (Model Number 96-2395M), which are blackhead extractors. The kits are being recalled due to packaging issues that may result in a breach of the sterile barrier.
The packaging defects create a risk that the sterile barrier protecting these medical procedure kits may be compromised. A breached sterile barrier may allow microbial contamination, potentially exposing users to infection or other adverse effects.
The recalled kits were distributed nationwide in the United States. The affected lot code is SK-133, with product quantities of 25 units per kit. The UDI/DI is 50649111448896.
Consumers and healthcare facilities that have received these kits should discontinue use and contact Sklar Instruments or their supplier for instructions on return or replacement. No illnesses or injuries have been reported to date.
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
- sterile-barrier-breach
- contamination-risk
- 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 (3)
- 96-2395M
- UDI/DI 50649111448896
- Lot codes: SK-133
Distribution
Distributed nationwide across the United States.
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