Sklar Instruments Recalls ECONO STERILE Medical Procedure Kits for Sterile Barrier Breach Risk
Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits nationwide due to packaging issues that may compromise the sterile barrier. No illnesses or injuries have been reported.
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 FDA Class II recall involves a risk-of-harm product (sterile medical instruments with potentially compromised sterile barriers) where no illnesses or injuries have been reported. The theoretical risk of contamination during surgical procedures meets the rubric criterion for High severity.
Plain-English summary
Sklar Instruments is recalling 245,015 ECONO STERILE medical procedure kits due to reports of various packaging issues that may result in a breach of the sterile barrier. The recall affects 54 different model numbers of sterile surgical instrument kits distributed nationwide in the United States.
The ECONO STERILE line includes surgical instruments such as forceps, hemostatic clamps, scissors, retractors, and other surgical tools. A breach of the sterile barrier in these kits could compromise the sterile integrity of the instruments used in medical procedures.
No illnesses or injuries have been reported to date in connection with this recall. Persons with questions about the recall should contact Sklar Instruments directly for further information and guidance.
The recalled product
- Product
- ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCP
- Manufacturer
- Sklar Instruments
- Hazard
- sterile-barrier-breach
- contamination-risk
- 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 (20)
- 1) 94-0286
- UDI/DI 50649111094406
- Lot codes: FSF21
- 2) 94-0290
- UDI/DI 50649111095045
- Lot codes: SK-115
- 3) 94-0291
- UDI/DI 50649111095144
- Lot codes: 824940291
- 924940291
- 4) 941-0691
- UDI/DI 50649111307902
- Lot codes: MST8
- MST9
- 5) 941-1414
- UDI/DI 50649111464872
- Lot codes: SK-122
- 6) 94-1924
- UDI/DI 50649111345775
- Lot codes: FSF16
Distribution
Distributed nationwide across the United States.
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