Medical procedure kit recall due to sterile barrier packaging breach risk
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
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 medical device recall with potential for harm through sterile barrier compromise, but no illnesses or injuries have been reported. The hazard is theoretical—packaging issues may result in barrier breach—and no realized harm has been documented.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE medical procedure kits for nasal procedures, with part numbers 96-2236, 96-2237M, and 96-2238. The recall affects 175 units that were distributed nationwide.
The kits are being recalled due to reports of packaging issues that may result in a breach of the sterile barrier. A compromised sterile barrier could allow contamination of the medical instruments, potentially affecting the safety of the nasal procedure.
Healthcare facilities and consumers who have received these kits should discontinue use immediately. Affected lot codes are SK-129, SK-130, SK-131 (for model 96-2236), SK-133 (for model 96-2237M), and SK-131 (for model 96-2238). Contact Sklar Instruments for instructions on replacement or safe disposal of affected kits.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal
- Manufacturer
- Sklar Instruments
- Affected units
- 175
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 (11)
- 1) 96-2236
- UDI/DI 50649111439757
- Lot codes: SK-129
- SK-130
- SK-131
- 2) 96-2237M
- UDI/DI 50649111439764
- Lot codes: SK-133
- 3) 96-2238
- UDI/DI 50649111439771
- Lot codes: SK-131.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 30 recalled by Sklar Instruments under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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