Medical Procedure Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were 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 with theoretical risk of harm from sterile barrier breach and no reported illnesses or injuries, placing this in the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE Curette Excavator Sterile surgical kits, Model 941-1320 (Lot Code 7249411320), due to reported packaging issues that may result in a breach of the sterile barrier.
A compromised sterile barrier could impact the sterility of the surgical instruments.
The affected kits were distributed nationwide. Customers who have received these kits should stop using them and contact Sklar Instruments or the FDA for further instructions.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
- 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)
- 941-1320
- UDI/DI 50649111469907
- Lot codes: 7249411320
Distribution
Distributed nationwide across the United States.
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