ECONO STERILE Procedure Kits Recalled for Sterile Barrier Breach Risk
Sklar Instruments is recalling ECONO STERILE medical procedure kits (Model 96-4921A) due to packaging issues that may result in a breach of the sterile barrier. The kits 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: This is an FDA Class II medical device recall involving potential harm (sterile barrier breach) with no reported injuries. Per the severity rubric, risk-of-harm products where injury has not been reported are classified as High (3).
Plain-English summary
Sklar Instruments is recalling ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25 medical procedure kits (Model 96-4921A, Lot FSF20) due to packaging issues that may result in a breach of the sterile barrier.
The kits are designed to remain sterile until opened for use. A breach of the sterile barrier could allow contamination to occur during procedures.
The recalled kits were distributed nationwide in the United States. Patients and healthcare facilities who have received these kits should discontinue use and contact Sklar Instruments for return instructions and product replacement.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination-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)
- 96-4921A
- UDI/DI 50649111493278
- Lot codes: FSF20
Distribution
Distributed nationwide across the United States.
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