ECONO STERILE Medical Procedure Kits Recalled for Sterile Barrier Compromise
Sklar Instruments recalls ECONO STERILE medical procedure kits (300 units nationwide) due to packaging issues that may compromise sterile barrier integrity.
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 recall for medical device packaging defects that compromise sterile barrier integrity. While no illnesses or injuries have been reported, the potential for serious infection from use of non-sterile surgical equipment in procedures constitutes a risk-of-harm situation.
Plain-English summary
Sklar Instruments is recalling ECONO STERILE medical procedure kits, specifically two models: Model 96-2630 (ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50) and Model 96-2636 (ECONO STERILE BACKHAUS TWL CLP STER 5.25 25). These are sterile general purpose surgical clips used in medical procedures. A total of 300 units have been recalled.
The kits are being recalled due to reports of various packaging issues that may result in a breach of the sterile barrier. If the sterile barrier is compromised, the surgical clips may become contaminated, potentially leading to infection during medical procedures.
The recalled kits were distributed domestically across the United States. Affected lot codes include SK-128 and SK-129 for Model 96-2630, and FSF14 for Model 96-2636.
Healthcare facilities and medical professionals who have received these kits should stop using them and contact Sklar Instruments. The affected units should be quarantined and not used in any procedures.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-compromise
- 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 (7)
- 1) 96-2630
- UDI/DI 50649111072350
- Lot codes: SK-128
- SK-129
- 2) 96-2636
- UDI/DI 50649111073524
- Lot codes: FSF14.
Distribution
Distributed nationwide across the United States.
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