ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was 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: FDA Class II recall of a medical device with packaging defects that may compromise the sterile barrier. No illnesses or injuries reported. Per the rubric, this represents a risk-of-harm product without reported injury, classified as High (3).
Plain-English summary
Sklar Instruments is recalling ECONO STERILE CEMENT SPATULA #24 STRL CS/25 (Model 96-2245M), a dental mixing utensil supplied as sterile packages of 25 units. The affected product was distributed nationwide under lot code 0724962245M.
The recall addresses reports of various packaging defects that may result in a breach of the sterile barrier. For a medical device packaged as sterile, compromise of package integrity affects the sterilization assurance of the product.
Users in possession of affected product should verify their lot number against code 0724962245M and contact Sklar Instruments or the FDA with questions about product replacement or proper handling.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-compromise
- 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)
- 96-2245M
- UDI/DI 50649111448612
- Lot codes: 0724962245M
Distribution
Distributed nationwide across the United States.
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