Sklar Instruments Recalls ECONO STERILE Gynecological Procedure Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits (Model 96-2478) due to packaging issues that may breach the sterile barrier and create contamination risk.
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 medical device with a packaging defect that may breach the sterile barrier and create infection risk in invasive gynecological procedures. No illnesses or injuries have been reported, placing this in the risk-of-harm category without confirmed patient harm.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE SIMS Uterine Sound procedure kits, Model Number 96-2478 with Lot Code SK-121, used in gynecological procedures. The kits are distributed nationwide.
The recall is due to various packaging issues that may result in a breach of the sterile barrier. A breach of the sterile barrier could allow contamination of the medical instruments, creating a risk of infection when used in patient care.
Healthcare facilities and providers using these kits should stop using them immediately and contact Sklar Instruments. Affected units can be identified by Model Number 96-2478 and Lot Code SK-121.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
- Manufacturer
- Sklar Instruments
- Hazard
- 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)
- 96-2478
- UDI/DI 50649111492615
- Lot codes: SK-121
Distribution
Distributed nationwide across the United States.
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